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​​​​​​​​​​​​​​​​Heart & Vascular Clinical Trials at The Edyth & Carl Lindner Research Center at The Christ Hospital Health Network​​

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Cardiothoracic Surgery

​​​Trial Name​​


​Description

​Primary Investigator

Study Details


​Reduce Atricure

​The fundamental goal of the Reduce registry is to improve the understanding of efficacy in cryoablation (cryoanalgesia) of the intercostal nerves for post-operative pain relief in cardiac and thoracic procedures. Cryoanalgesia uses extreme cold to freeze peripheral nerves and create a temporary yet fully recoverable loss of sensory nerve function.Non-randomized post market registry.Sponsor is AtriCure, Inc.​
 ​Julian Guitron, MD
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​Triomphe

​Evaluating safety and effectiveness of the Nexus aortic arch stent graft system for the endovascular treatment of thoracic aortic lesionsinvolving the aortic arch including chronic dissections, aneurysms, penetrating aortic ulcers and intramural hematoma.  Non-randomized. Sponsor: Endovascular Ltd.
 ​Geoffrey Answini, MD
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Cardiovascular Disease

​Trial Name

​Description

​Primary Investigator

​Study Details

​Evoid
​Study to evaluate efficacy and safety of DA-1229 (Evogliptin) compared to placebo in patients with calcific aortic valve disease with mild to moderate aortic stenosis. Study has 3 arms Placebo group, DA-1229 5 MG, and DA-1229 10 mg. Adaptive Phase 2/3 multicenter, double-blind, placebo-controlled, randomized, parallel, 3 arm study. Sponsor: Rednvia Co, Ltd
​Eugene Chung, MD
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Congestive Heart Failure/Medication/Device/HCM

​Trial Name

​Description

​Primary Investigator

​Study Details

​Cordio
​To determine the sensitivity of Cordio HearO in detecting impending episodes of heart f​ailure decompensation requiring intervention. The Cordio HearO app remotely monitors patients by detecting changes in the patients' recorded voice relative to a baseline. Changes in vocal parameters and deterioration of heart failure patients is the impact of HF-induced edema on the vocal tract and on the and on the organs that produce the vocal excitation. Nonrandomized. Sponsor is Cordio Medical.
​Eugene Chung, MD
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​ALT Flow EFS (Device)
​Early feasibility study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, non-randomized, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System. Sponsor: Edward Life Sciences
​Santiago Garcia, MD
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​ALT Flow (Device)
​Study to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system (ALT Flow II) when used for the treatment of patients with heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (LVEF >40%). The Edwards APTURE transcatheter shunt system is intended for transcatheter treatment of symptomatic left-sided heart failure Randomized, sham-controlled, blinded (patient and evaluators) feasibility trial. Sponsor: Edward Life Sciences.
​Santiago Garcia, MD
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​BiVACOR TAH EFS (Device)
​Purpose of study is to assess the feasibility of the BiVACOR Total Artificial Heart (TAH) System to support adult patients with severe biventricular heart failure, or univentricular heart failure in which left ventricular assist device (LVAD) support is not recommended, who require mechanical circulatory support to sustain life. The BiVACOR TAH System is intended for use as a bridge to transplant (BTT). Feasibility will be assessed by evaluating safety and performance. Sponsor: BiVACOR
 ​Robert Dowling, MD
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​Competence (Evaheart) (Device)
​This study is comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3 LVAS).Evaheart LVAS is a continuous flow centrifugal pump employing a hydrodynamic impeller levitation system designed to preserve arterial pulsatility, minimize blood trauma, minimize blood stagnation and clot formation and lower risk of ventricular septal suction.Randomized 2:1 (EVA2 : HM3) for study enrollment in the initial safety cohort and the expanded cohort.Sponsor is Evaheart, Inc
 ​Gregory Egnaczyk, MD
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​CORCINCH-HF (Device)
 ​Evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with symptomatic heart failure and reduced ejection fraction.The AccuCinch implant draws in the LV free wall (reducing its radius by ~ 10 mm) which facilitates subsequent LV reverse remodeling and improved LV function over time.Randomized 1:1 ratio: Treatment - AccuCinch system plus guideline-directed medical therapy versus Control - guideline-directed medical therapySponsor is Ancora Heart, In
 Dean Kereiakes, MD
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​​Doraya-HF EFS (Device)
​The study is to evaluate the feasibility of the Doraya Catheter and measure clinical performance and safety endpoints, in the acute heart failure with insufficient response to diuretics.The Doraya device is a central venous catheter, placed in the IVC below the renal veins, applying partial and controlled, adjustable flow. The flow regulator mechanism reduces CVP and renal afterload, thus enabling improved patient response to diuretic therapy.Nonrandomized trial.Sponsor is Revamp medical.
​Eugene Chung, MD
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​Empower (Device)

​The objective of this blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).The implant is designed to be deployed, tensioned, and locked in the coronary vein in order to reshape the mitral annulus and thus reduce mitral annular dilation and mitral regurgitation.Randomization is 1:1 allocation to the Intervention or Control. PT IS BLINDED DON'T DISCLOSE.Sponsor is Cardiac Dimensions In
​Sitaramesh Emani, MD
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​Responder HF (Device)

​The Corvia Atrial Shunt System indicated for the improvement in QOL and reduction of HF related symptoms and events in patients with heart failure with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF) with elevated left atrial pressures, without latent pulmonary vascular disease and without a cardiac rhythm device, who remain symptomatic despite standard GDMT Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Trial, with1:1 randomization. Sponsor: CORVIA
​Eugene Chung, MD
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​Vectorious Vector-HF Early Feasibility (Device)

​The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction. The V- LAP™ System is intended for wirelessly measuring and monitoring LAP. The V-LAP™ System is indicated for subjects with chronic symptomatic ACC/AHA Stage C subjects Heart Failure. A Multi-center, National, Open Label, Prospective Study. Sponsor: Vectorious Medical
​Sitaramesh Emani, MD
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​Cytokinetics (HCM)

​This trial will study the safety and efficacy of the effects of Aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy. Aficamten is designed to reduce the hypercontractility that underlies the pathophysiology of HCM. A phase 3, multi center, randomized, double blind. Sponsor: Cytokinetics, INC
​Ankit Bhatia, MD
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​EDG-7500-102 Edgewise (HCM)

​Trial to evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of EDG-7500 in Adults with Obstructive Hypertrophic Cardiomyopathy. Will explore effects on LVOT Obstruction, determine the single- and multiple dose PK of med as well. Trial is a 2-part, open-label study. Part A of the study participant administered a single dose of EDG-7500. Part B of the study is an optional multiple-dose treatment period, participant will receive EDG-7500 once daily for up to 28 days.
​Ankit Bhatia, MD
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​MyPEAK (HCM)

​Study designed to evaluate the safety, tolerability, and pharmacodynamics (PD) of TN-201 in adult patients with symptomatic MYBPC3 mutation-associated nonobstructive hypertrophic cardiomyopathy (nHCM). First-in-human, non-randomized trial and will consist of 2 escalating dose cohorts. The study will follow patients for 5 years following a single dose of TN-201. Sponsor: Tenaya Therapeutics
 ​Wojciech Mazur, MD
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​Sonata (HCM)

​Study to Evaluate the Efficacy and Safety of Sotagliflozin in symptomatic obstructive and non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM. Study will determine the changes in symptoms and functional limitations in participants with symptomatic hypertrophic cardiomyopathy (HCM) treated with Sotagliflozin as compared to placebo. Sponsor: Lexicon Pharmaceuticals, INC
​Ankit Bhatia, MD
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​Ask CHF2-CS201 (Medication)

​Trial to evaluate the safety and efficacy of a single antegrade intracoronary artery infusion of 3 dose levels of AAV2i8 capsid expressing the transgene for I-1c (AAV2i8.I-1c or NAN-101) in subjects with non-ischemic cardiomyopathy and NYHA Class III symptoms of HF. Phase 2, double-blinded, placebo controlled, and randomized. Sponsor Askelepios Biopharmaceutical, INC
 ​Timothy Henry, MD
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​ATTR-CM (ION-682884-CS2) (Medication)

​To evaluate the effect of treatment with ION‑682884 compared to placebo for 120 weeks on cardiovascular mortality and recurrent CV clinical events in patients with ATTR-CM.ION‑682884 is an antisense drug targeted to human TTR mRNA and its hybridization to the cognate TTR mRNA results in the RNase H1-mediated degradation of the TTR mRNA preventing production of the TTR protein.Randomized 1:1 to receive either ION‑682884 45 mg or placebo SC once every 4 weeks.Sponsor is Ionis Pharmaceuticals
​Timothy Raymond, DO
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​IONIS ION 682884-CS12 Open Label (Medication)
​An Open Label Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM). Eligible participants will receive eplontersen once every 4 weeks for up to 36 months or 6 months after eplontersen is approved and available in the site's country, whichever occurs first. Participants will also receive daily supplemental doses of the recommended daily allowance (RDA) of vitamin A. Sponsor: Ionis Pharmaceuticals
​Timothy Raymond, DO
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​NanoCor (Medication)

​To evaluate the safety of a single antegrade epicardial coronary artery infusion of 3 dose levels of NAN-101 to subjects with non-ischemic cardiomyopathy and NYHA Class III symptoms of heart failure.NAN-101 is a gene therapy product composed of a novel chimeric cardiotropic adeno-associated virus AAV2/AAV8 vector capsid (AAV2i8) and a cassette expressing a constitutively active form of I-1c.Non-randomized open-label.Sponsor is NanoCor Therapeutics, Inc. / Asklepios BioPharmaceutical.​
​​Timothy Henry, MD
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​Reneu HF (Medication)
​A Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure. There will be 2 Cohorts in study. Cohort 1 -Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40% and Cohort 2 -Heart failure (HF) participants with left ventricular ejection fraction (LVEF) > 40% and ≤ 65%. Phase 2 Randomized, Double-blind, Placebo-controlled. Sponsor: Salubris Biotherapeutics, INC
​Sitaramesh Emani, MD
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​Reverse - HF (Medication)

​Study to evaluate clinical outcomes of adjustable ultrafiltration with the Aquadex System as compared to adjustable loop diuretics in patients with an acute exacerbation of chronic heart failure (HF) and congestive physiology who are unresponsive to medical management. Patients with chronic heart failure, already established on outpatient diuretic therapy, hospitalized with an episode of decompensation with clear evidence of int volume overload will be evaluated. Sponsor: Nuwellis
​Sitaramesh Emani, MD
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Electrophysiology​​​​

​Trial Name

​Description

​Primary Investigator

​Study Details

​Backbeat


​Evaluating safety/effectiveness of novel atrioventricular interval modulation (AVIM) algorithm downloaded into previously implanted dual-chamber Medtronic Astra/Azure DR MRI IPG. Three phases: 1)Screening/ Run-in, 2)Double-blind Randomized (1 year), and 3) Randomized unblinded (2 years). Patients within 90 days of de novo implant Medtronic Astra/Azure pacemaker having uncontrolled hypertension may be approached. During Double-blind Randomized, control group will receive SOC pacemaker/HTN therapy
​Edward Schloss, MD
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​Cryo AF Global Registry

C​linical trial to evaluate and describe clinical performance and safety data in a broad patient population treated with the Arctic Front Family of cardiac cryoablation catheters and followed according to the standard of care (SOC). A non randomized trial. 2 Registries Stop Persistent and Stop AF FirstSponsor is Medtronic.
​Daniel Beyerbach, MD
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​Disrupt AF

​Registry designed to obtain clinical experience with the Farapulse Pulsed Field Ablation System for the treatment of atrial fibrillation (AF). All types of AF including paroxysmal, persistent and long standing persistent may be included. The registry will utilize real world clinical data obtained from the use of commercially available technologies under the authority of a health care practitioner within a legitimate practitioner-patient relationship. Sponsor: Heart Rhythm Clinical & Research
​Daniel Pelchovitz, MD
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​​Heal-IST IDE
​Hybrid Epicardial and Endocardial Sinus-Node Sparing Ablation Therapy to evaluate the safety and effectiveness of a hybrid sinus node sparing ablation procedure for the treatment of symptomatic drug refractory or drug intolerant Inappropriate Sinus Tachycardia (IST). IST is a prevalent and debilitating condition in otherwise healthy younger patients, resulting in significant loss of quality of life, lacking effective treatment options or systematic clinical evidence to support a therapy.
 ​J. Michael Smith, MD
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​IST Registry

​Registry to capture the real-world data on the outcome of AtriCure Isolator® Synergy™ Surgical Ablation system (or future iterations) when used to ablate cardiac tissue in patients with Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS) using sinus node sparing hybrid ablation procedures. This is an observational, retrospective and prospective, multicenter, open-label patient registry. Sponsor: AtriCure, INC
​Daniel Pelchovitz, MD
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​LeAAPs
​SUBJECTS MUST REAMIN BLINDED AT ALL TIMES. DECISIONS ON ANTICOAGULATION SHOULD BE BASED UPON STANDARD OF CARE AND NOT THE ASSIGNED TREATMENT ARM. To demonstrate the effectiveness of LAA exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke. Subjects will be randomized in a 1:1 to treatment arm or the control arm without LAAE. Sponsor: Atricure, Inc.
​J. Michael Smith, MD

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​LEADR LBBAP

​The LEADR study is designed to confirm the safety and defibrillation efficacy of the Next Generation ICD Lead when placed in the LBBAP location in ICD and LOT-CRT patient population. Subjects who are indicated to receive an implantable single or dual chamber ICD, or CRT-D who meet I/E criteria will be considered. Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP) Sponsor: Medtronic
​Edward Schloss, MD
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​Left vs Left RCT
​Randomized Trial to evaluate the comparative effectiveness His or Left bundle branch pacing (His/LBBP) vs. biventricular pacing (BiVP) in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) & with either a wide QRS (≥130 ms) or with/anticipated >40% pacing who are already receiving current standard heart failure pharmacological therapy by assessing all cause death & heart failure hospitalization at the end of the study. Sponsor: Patient-Centered Outcomes Research
​Edward Schloss, MD

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​Librexia - AF
​Study to evaluate efficacy and safety if Milvexian (new class of anticoagulants that is direct-acting, reversible, high-affinity inhibitor of activated human coagulation Factor XI (Factor XIa or FXIa) for prevention of cardioembolic events in patients with AF is non inferior to apixaban for the composite of stroke and non-CNS systemic embolism. Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active-Controlled Study. Sponsor: Janssen Research
​Andrew Noll, MD
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​React AF

​Trial of Rhythm Evaluation for AntiCoagulation With Continuous Monitoring of Atrial Fibrillation. Comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk. Sponsor: Northwestern University NIH Supporting Grant #UG3HL15065
​Daniel Pelchovitz, MD
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​Real AF
​Trial to assess clinical outcomes, including: procedural efficiency, safety, and the long-term effectiveness of RF ablations. REAL AF Registry is an observational, prospective, multi-center, non-randomized registry designed to obtain real-world clinical experience of Paroxysmal and Persistent ablation using Biosense Webster CARTO technologies including THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF, and any new technologies as they become commercially available. Sponsor Heart Rhythm Clinical
​Alexandru Costea, MD
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​Real AF EVERCOOL Sub-Study
​Sub-study of the Real AF Registry examining the effectiveness of active esophageal cooling on subjects undergoing left atrial ablation for symptomatic Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation in areas of procedural efficiency, success, and safety. Sponsor: Heart Rhythm Clinical and Research Solutions, LLC
​Alexandru Costea, MD
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​Real AF QDOT PAS Sub-study
​Subjects with symptomatic paroxysmal atrial fibrillation (PAF) enrolled in the REAL AF registry. Subjects will be treated with the commercially available QDOT MICRO™ system (QDOT MICRO™ catheter and nGEN™ generator) in conjunction with VISITAG SURPOINT™ Module. Subjects are required to complete scheduled assessments within 12 months of the index procedure, and additional two assessments at 24 and 36-months post procedure. Observational, multi-center, non-randomized, post-market study.
​Alexandru Costea, MD

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​Surveillance
​The purpose of the Product Surveillance Registry (PSR) platform is to provide continuing evaluation and periodic reporting of safety and effectiveness of market-released products for their intended use. PSR data will support post-market surveillance activities initiated by Medtronic and post-approval studies directed by a government and/or a regulatory authority.Non randomized data collection only.Sponsor is Medtronic, Inc.​
​Puvi Seshiah​, MD
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​Cardiovascular Risk Reduction


​Trial Name

​Description

​Primary Investigator

​Study Details

​Amgen 20190218
​A Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus Sponsor: Amgen
​Timothy Henry, MD
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​Bolt
​To demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in obstruction due to deep vein thrombosis.The Indigo Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus while the Lightning Aspiration Tubing is designed to assist in thrombus removal and restoration of blood flow by providing intermittent or continuous aspiration.Non Randomized prospective trial.Sponsor is Penumbra, Inc.
​Daniel Long, MD
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​Dal-GenE-2
​Trial to evaluate the potential of dalcetrapib to reduce the occurrence of fatal and non-fatal myocardial infarction in subjects with a documented recent hospitalization for ACS and the AA genotype at variant rs1967309 in the ADCY9 gene Phase III, Double-blind, randomized placebo-controlled study. Sponsor: DalCor Pharmaceuticals
​Timothy Henry, MD
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​Frontier CAVS Lp(a)

​Study to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis. Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis. Sponsor: Novartis Pharmaceticals
​Sitaramesh Emani, MD
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​Resonance Registry

​The registry will focus on furthering the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical man​agement of RP patients to optimize clinical outcomes. It also aims to generate data in support of the impact of rilonacept on clinical outcomes in the real-world Spnonsor: Kiniska Pharm
​Timothy Henry, MD
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Interventional Cardiology

​Trial Name

​Description

​Primary Investigator

​Study Details

​ALL-RISE
​​Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment. Trial to assess FFRangio-guided treatment is noninferior to conventional pressure wire-guided treatment in patients w/ chronic coronary syndromes (CCS) and non-ST elevation acute coronary syndromes (NSTEACS) undergoing coronary angiography who have a coronary lesion(s) deemed appropriate being evaluated for percutaneous coronary intervention (PCI) with respect to major adverse cardiac events at one year. Sponsor: CathWorks
​Santiago Garcia, MD
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​Artemis
​Trial to Access Effects of ziltivekimab versus placebo on cardiovascular outcomes in patients with acute myocardial infarction.Ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Sponsor: Novo Nordisk
​Timothy Henry, MD
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​Ceramics Study
​CERAMICS: Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock. Goal to gather data and outcomes of patients with AMICS who meet criteria. The study is expected to collect data for ~2 years. All study data collection is occurring retrospectively at each time-point only using EMR, and there will be no contact between study personnel and patients. Patients will be discharged or deceased at the time of study entry. Sponsor Henry Ford Health
​Santiago Garcia, MD
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​Cosira-II
​To demonstrate the safety and effectiveness of the Reducer system for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. The COSIRA-II study is randomized (1:1 ratio), double-blinded, sham-controlled clinical trial. Sponsor is Neovasc Medical Inc
​Timothy Henry, MD
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​Discover INOCA
​The overall objective of this multi-center registry is to identify specific phenotypes of INOCA with both an anatomic evaluation (coronary angiography and intravascular imaging) and physiologic assessment with the Abbott Coroventis Coroflow Cardiovascular System, and to determine long-term outcomes.No investigational equipment or procedures.Non-randomized registry.Sponsor is Yale Cardiovascular Research Group.
​Timothy Henry, MD
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​Disrupt CAD Duo Study
​Study to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter. Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting. Single-Arm IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter. Sponsor: Shockwave Medical, Inc
 ​Jarrod Frizzell, MD

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​Disrupt PAD BTK II

​Post market study to assess the continued safety, effectiveness, and optimal clinical use of the Shockwave Medical Peripheral IVL System for the treatment of calcified, stenotic below the knee arteries.The balloon catheter system is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium-disrupting capability of lithotripsy prior to balloon dilatation at low pressures. Nonrandomized.Sponsor is Shockwave Medical, Inc.
 ​John Corl, MD
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​Empower CAD
​Equity in Modifying Plaque Of WomEn with UndeRtreated Calcified Coronary Artery Disease (EMPOWER CAD) Observational Trial to generate real-world clinical evidence associated with Coronary IVL in a population of female subjects with calcified coronary artery disease referred for percutaneous coronary intervention (PCI) with coronary IVL and stenting Aper standard of care.  Post market, prospective multi center single arm. Sponsor: Shockwave Medical. INC
​Odayme Quesada, MD
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​Forward IDE Shockwave

​Trial to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries. The Shockwave Medical IVL System is intended for lithotripsy-enhanced treatment of lesions, including calcified lesions, to increase luminal diameter, allowing for further treatment (e.g. post-dilatation) in the peripheral arterial vasculature. Subjects with severely calcified PAD. Sponsor: Shockwave Medical INC
​Christopher Paprzycki, MD
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​HARP
​This is a diagnostic observational study enrolling patients referred for a cardiac catheterization with a diagnosis of a MI. The study will employ standardized imaging protocols in patients with MINOCA to determine the prevalence and composition of disrupted plaque and the prevalence and location of myocardial abnormalities.Observational study - no randomization.Sponsor is American Heart Association
​Odayme Quesada, MD
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​LOQI Impella Registry
​Long-Term Outcome and Quality Indicator (LOQI) Impella Registry to capture observational data of Abiomed hemodynamic support device systems in real-world setting. Population enrolled in study are subjects who received an Impella and subjects in whom an Impella placement was attempted. Data collection will include routine medical care data and support the reporting of specific safety events and device practices. Data will be entered from index hospitalization through 1-year post. Sponsor Abiomed
​​Robert Dowling, MD
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​Micro 2
​Trial to validate CardioFlux MCG's ability to diagnose myocardial ischemia caused by coronary microvascular dysfunction in patients with suspected ischemia and confirmed no obstructive coronary artery disease (suspected INOCA) by using diagnostic measures of coronary flow reserve (CFR) via invasive angiography as a reference standard for diagnosis. Prospective, multicenter, observational, single-arm. Sponsor: Genetesis, INC
​Odayme Quesada, MD
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​Protect IV
​The primary objective is to demonstrate the superiority of PCI performed with Impella mechanical circulatory support compared with PCI without Impella in high-risk patients with reduced left ventricular ejection fraction undergoing PCI of complex coronary artery disease.Impella devices are currently FDA-indicated for providing temporary (<6 hours) support in high risk PCI.Randomization is 1:1 to PCI with Impella versus standard of care PCI with or without IABP.Sponsor is Abiomed, Inc.
 ​Steven Rudick, MD
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​Selution 4DeNovo
​Clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm. Prospective, randomized controlled, single-blind, multicenter, clinical trial. Control: Randomized to the DES arm will receive treatment using any FDA approved 'limus-based' DES, as per standard institutional practice. Sponsor: MedAlliance
​Jarrod Frizzell, MD
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​Selution SLR 014 ISR
​Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Subjects with In-stent Restenosis. Eligible Subjects will be randomized to comparator device which is standard of care (SOC) control group using contemporary drug eluting stent (DES) or non-DEB balloon angioplasty (BA). Sponsor MedAlliance LLC
​Jarrod Frizzell, MD
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​Short-Cut
​Trial that is designed to compare the efficacy of cutting balloon angioplasty vs. intravascular lithotripsy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries. The trial will be composed of two cohorts: Patients treated with up-front rotational atherectomy, and Patients in whom atherectomy is not planned. The trial is designed to demonstrate non-inferiority between cutting balloon angioplasty and intravascular lithotripsy. Sponsor: Baim
​Jarrod Frizzell, MD
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​Spyral Affirm
​The SPYRAL AFFIRM Study will evaluate the long-term safety, efficacy, and durability of the Symplicity Spyral system of Renal Denervation in subjects with uncontrolled Hypertension and subjects with varying severity of hypertension and associated comorbidities. Study is a multi-center, international, prospective, interventional, single arm with two cohorts Main Cohort with ABPM subset (first 250 subjects in main cohort) and Continuation Cohor. Sponsor Medtronic Vascular.
​​John Corl, MD
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​Vis-RX-Prime
​The aim of this clinical evaluation is to assess the performance of the Gentuity HF-OCT Imaging System with the Vis-Rx Prime Micro-Imaging Catheter in a real-world setting. The objective is to evaluate the clinical and technical performance in the target patient population. This evaluation will collect safety and performance data for the system in a real-world clinical setting in patients who are candidates for PCI, including imaging both pre- and post intervention. Sponsor: Genutity
​Timothy Henry, MD
 ​Learn More​

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Peripheral Vascular Disease

​Trial Name

​Description

​Primary Investigator

​Study Details

​Unitary Supplement
​To evaluate the benefit of the TAAA debranching stent graft system indicated for the endovascular treatment of short-neck infrarenal, pararenal, juxtarenal, and Crawford type 4 thoracoabdominal aortic aneurysms.The unitary stent graft is made of one aortic stent graft component and several off-the-shelf FDA-approved iliac and peripheral stent grafts.Non-randomized trial. The patient can be enrolled in the Unitary stent graft arm or the Expanded selection arm.Sponsor is Geoffrey Answini.
 ​Geoffrey Answi​ni, MD
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Pulmonary Hypertension

​Trial Name

​Description

​Primary Investigator

​Study Details

​A011-13 (HYPERION)
​To evaluate the effects of Sotatercept treatment (plus background PAH therapy) on time to clinical worsening in newly diagnosed patients who are at risk for disease progression.Sotatercept is a first-in-class human fusion protein consisting of the extracellular domain of the activin receptor IIA (ActRIIA) linked to the Fc domain of human IgG.Randomized 1:1 to placebo or Sotatercept at a starting dose of 0.3 mg/kg, with a target dose of 0.7 mg/kg. Sponsor is Acceleron and BMS.
​Peter Engel, MD
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​A011-16 (Cadence)
​A Phase 2, Double-blind, Randomized, Placebo Controlled Study to Evaluate the Effects of Sotatercept  versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF). Sponsor Acceleron Pharma Inc.
​Peter Engel, MD
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​Aspire PH
​An Early Feasibility, Single Arm Study Assessing Treatment of PAH Using the Aria CV Pulmonary Hypertension System (ASPIRE PH) The purpose of this study is to validate that the clinical use of the Aria CV PH System is safe for the patient, and to evaluate its performance in treating patients with PAH. The Aria CV PH System is designed to compensate for the lack of elasticity and compliance in the pulmonary arterial vasculature in patients with PAH. Sponsor Aria CV, INC
​Peter Engel, MD
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​Soteria
​This Phase 3 study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept in PAH.Sotatercept (ACE-011) is a first-in-class human fusion protein consisting of the extracellular domain of the activin receptor IIA (ActRIIA) linked to the Fc domain of human IgG.Non-randomized. Subjects will begin sotatercept treatment at a dose of 0.3 mg/kg (SC) and be titrated up to 0.7 mg/kg every 21 days.Sponsor is Acceleron Pharma Inc.
​Peter Engel, MD
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​Unisus
​Event-driven study to compare efficacy, safety, and tolerability of Macitentan 75 mg Versus Macitentan 10 mg in patients (PH Group 1) with pulmonary arterial hypertension.Macitentan is an endothelin receptor antagonist.Randomized  1:1 ratio to 10 mg versus 75 mg macitentan. There will be an open-label extension phase.The sponsor is Actelion Pharmaceuticals LTD.​​
​Peter Engel, MD
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Structural Heart Disease

​Trial Name

​Description

​Primary Investigator

​Study Details

​ALIGN AR-HDE (JenaValve) (Aortic)
​To evaluate the safety and probable benefit of the transfemoral JenaValve Pericardial TAVR System in a patient population with symptomatic severe AR requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair.The JenaValve includes three positioning Locators which enable a correct positioning and re-positioning of the prosthesis into the cusps of the native aortic valve.Non randomized.Sponsor is JenaValve Technology,
​Dean Kereiakes, MD
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​Alliance AVIV (Aortic)
​The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater surgical risk with a failing aortic surgical bioprosthetic valve.SX4 is a balloon-expandable Resilia bovine pericardial tissue valve with a outer fabric skirt. The Resilia valve incorporates an anticalcification process with tissue preservation that replaces the traditionNon-randomized trial.Sponsor is Edwards Lifesciences
​Santiago Garcia, MD
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​Echocath (Aortic)
​Randomized Study to compare the changes in QOL following valve-in-valve TAVR guided by Doppler-echocardiography vs. Catheterization measurements. Trial Title: Valve Hemodynamic Optimization Based on Doppler Echocardiography Versus Catheterization Measurements following Valve in Valve TAVR. For patients with surgical aortic bioprosthetic dysfunction in the presence of a stented surgical valve referred for a valve-in-valve TAVR procedure with the SAPIEN 3 Ultra valve. Sponsor: IUCPQ-ULavale.
​Santiago Garcia, MD
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​Envision (Aortic)
​Trial to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. Subjects in this clinical investigation will be randomized between the Navitor TAVI Implantation System (test arm) and any commercially available transcatheter aortic valve system (CAV) (control arm) in a 1:1 ratio. Sponsor: St. Jude Medical Business Services, Inc., an Abbott Company
​Santiago Garcia, MD
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​J-Valve Journey (Aortic)
​Study to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR). Prospective, single arm, multi-center, interventional pivotal study. Subjects will be followed for 5 years post procedure. Sponsor: JC Medical, INC
​Santiago Garcia, MD
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​Apollo (Mitral)

​This trial will evaluate the safety and efficacy of the Medtronic Intrepid TMVR System in patients with moderate‐to‐severe or severe symptomatic mitral regurgitation.The system has a nitinol stent and woven polyester skirt which supports a bovine bioprosthetic valve.The trial is non randomized and includes a MAC cohort.Sponsor is Medtronic Inc.

​Puvi Seshiah​, MD
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​CLASP II D/II F (Mitral)

​To evaluate the safety and effectiveness of the PASCAL System for transcatheter mitral valve repair treatment of degenerative and functional mitral regurgitation. The Edwards Pascal Mitral Valve Clasp design has shown technical success and effectiveness in patients with complex anatomies and suggests that the PASCAL System addresses an unmet clinical need.Randomization for degenerative is 2:1 while functional is 1:1, PASCAL versus MitraClip.The sponsor is Edwards Lifesciences, LLC.
​Santiago Garcia, MD
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​Encircle (Mitral)

​To establish the safety and effectiveness of the Sapien M3 System in subjects with symptomatic mitral regurgitation for whom commercially available surgical or transcatheter treatment options are deemed unsuitable.The Edwards Sapien M3 valve is comprised of a balloon-expandable, cobalt-chromium frame, trileaflet bovine pericardial tissue valve, polyethylene terephthalate fabric inner skirt, and a PET outer cloth cover. Non-randomized trial.Sponsor is Edwards Lifesciences LLC.
​Santiago Garcia, MD
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​Repair MR (Mitral)
​The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.  Sponsor: Abbott
​Santiago Garcia, MD
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​Innoventric Trillium (Tricuspid)
​Early Feasibility Study to evaluate the safety and performance of the Innoventric Trillium™ Stent Graft in the treatment of severe or greater tricuspid regurgitation (TR). The stent Graft is intended for patients with severe or greater, symptomatic, primary or functional tricuspid regurgitation (TR), who remain symptomatic despite treatment with optimal medical therapy, and are high risk for standard-of-care open surgical therapy, and who are deemed appropriate. Sponsor: Innoventric, LTD
​Santiago Garcia, MD
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​Medtronic Tricuspid EFS (Tricuspid)
​Trial to Evaluate the Safety and Performance of The Medtronic Intrepid Transcatheter Tricuspid Valve Replacement System with Transfemoral access in Patients with symptomatic severe tricuspid regurgitation. Objective of this early feasibility study to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system to deliver a self‐expanding bioprosthetic valve within the tricuspid valve. Non Randomized. Sponsor: Medtronic
​Puvi Seshiah​, MD
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