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

Clinical Trials

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	Learn More
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	Learn More

Cardiovascular Disease

Trial Name	Description	Primary Investigator	Study Details
EXAC 2 XC001	Trial to assess the safety, feasibility, and efficacy of percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with refractory angina (RA) due to obstructive coronary artery disease (CAD). Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (with 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study. Sponsor: Xylocor Therapeutics	Timothy Henry, MD	Learn More

Congestive Heart Failure/Medication/Device/HCM

Trial Name	Description	Primary Investigator	Study Details
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
Amber HFpEF (Medication)	Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-4021586 in Adults with Symptomatic Heart Failure with Preserved Ejection Fraction. Randomized, Double-Blind, Placebo Controlled study. CK-4021586 is a small molecule cardiac myosin inhibitor being developed as a chronic oral treatment for participants with heart failure with preserved ejection fraction (HFpEF). Sponsor: Cytokinetics	Ankit Bhatia, MD	Learn More
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	Learn More
AXLN2350 BAG3 (Medication)	Study investigating the safety, tolerability, and efficacy of a single IV infusion of ALXN2350 in adult participants with BAG3 associated DCM. This Phase 1/2 study is an open-label, dose finding and dose expansion ALXN2350 is being developed with the intent to be a one-time disease-modifying gene therapy for the treatment of patients with DCM who have confirmed pathogenic or likely pathogenic BAG3 mutations. ALXN2350 is an AAV9 gene therapy intended for the treatment of DCM. Sponsor: Alexion	Gregory Egnaczyk, MD	Learn More
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	Learn More
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	Learn More

Electrophysiology

Trial Name	Description	Primary Investigator	Study Details
Cryo AF Global Registry	Clinical 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	Learn More
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	Learn More
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	Learn More
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	Learn More
Laminar LAAX IDE	Trial for Safety and Efficacy and comparison of the Laminar Left Atrial Appendage Closure System to commercially available left atrial appendage closure devices. Study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternatives. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device. Sponsor: Laminar Inc	Santiago Garcia, MD	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More

Cardiovascular Risk Reduction

Trial Name	Description	Primary Investigator	Study Details
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	Learn More
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	Learn More
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 management 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	Learn More

Interventional Cardiology

Trial Name	Description	Primary Investigator	Study Details
Agent IDE	To assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to POBA in patients with in-stent restenosis.Agent DCB is based on the commercially available Emerge PTCA catheter and has features to allow a reduced paclitaxel dose density.Randomization is 2:1 AGENT to POBA. If a subject is randomized to POBA and presents with symptomatic severe restenosis within 12 months, they can crossover to the Agent device.Sponsor is Boston Scientific Corporation.	Steven Rudick, MD	Learn More
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	Learn More
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	Learn More
Kardion Picante	The purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support during a high-risk PCI procedure.The CORY P4 System is indicated for use during high-risk percutaneous coronary interventions, lasting 6 hours or less, performed in hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction. Randomized to Control Impella CP. Sponsor: Kardion, INC	Jarrod Frizzell, MD	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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

Peripheral Vascular Disease

Trial Name	Description	Primary Investigator	Study Details
Magical BTK	This clinical trial is to determine the effectiveness and safety of the sirolimus drug coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of below the knee arterial disease. Eligible subjects will be randomized in a 1:1 to MagicTouch PTA sirolimus coated balloon catheter (DCB) in addition to standard balloon angioplasty or Placebo balloon angioplasty in addition to standard balloon angioplasty (PTA). Sponsor: Concept Medical, Inc.	John Corl, MD	Learn More
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 Answini, MD	Learn More

Pulmonary Hypertension

Trial Name	Description	Primary Investigator	Study Details
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	Learn More
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	Learn More
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	Learn More

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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
Restore (Aortic)	The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).Subjects with symptomatic heart disease due to bioprosthetic valve failure (BVF) affecting TAVs and requiring redo Transcatheter Aortic Valve Replacement (TAVR).The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo TAVR. Sponsor: Medrtonic	Puvi Seshiah, MD	Learn More
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	Learn More
Cardiomech EFS (Mitral)	The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (3+) or severe (4+), symptomatic, degenerative mitral regurgitation with prolapse or flail of the P2 leaflet segment, and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site’s multidisciplinary heart team. Sponsor: CardioMech AS	Santiago Garcia, MD	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More
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	Learn More