​​​​​​​Structural Heart Disease Fellowship Clinical Trials & Publications

List of Active Clinical Trials

For more information about cardiovascular clinical research at The Christ Hospital, visit the Lindner Rese​arch Center.

Aortic

Mitral

Tricuspid

Pulmonic

Interventional Heart Failure Trials (Shunt devices, etc)

Recent Publications by Structural Heart Disease Faculty ​

1. Cubeddu RJ, Murphy SME, Asher CR, Garcia SA, Granada JF, Don CW, Patel S, Albaghdadi MS, Cavalcante JL, Coylewright M, Hahn RT, Genereux P, Yadav PK, Thourani VH and Leon MB. Association of ACEI/ARB and statin prescribing patterns with mortality after Transcatheter Aortic Valve Replacement (TAVR): Findings from real-world claims data. Am Heart J. 2022;258:27-37.
2. Seshiah P, Garcia S, Choo J et al. Lithotripsy-Assisted Transcatheter Mitral Valve Replacement for Severe Mitral Annular and Valve Calcification. JSCAI 2023.
3. Griffin ACG, Yildiz M, Bradley S, Smith JE, Garcia S, Schmidt CW, Garberich R, Walser-Kuntz E, Traverse J, Jollis JG, Sharkey SW and Henry TD. Frequency and outcomes of STEMI patients presenting between 12 and 24 h after symptom onset: Late-presenting STEMI. Catheter Cardiovasc Interv. 2023;101:1-10.
4. A.A. Kuchtaruk, R.T. Sparrow, L. Azzalini, S. Garcia et al., Unplanned readmissions after Impella mechanical circulatory support, International Journal of Cardiology (2023), https://doi.org/10.1016/j.ijcard.2023.03.013
5. Chhatriwalla AK, Allen KB, Depta JP, Rodriguez E, Thourani VH, Whisenant BK, Zahr F, Bapat V and Garcia S. Outcomes of Bioprosthetic Valve Fracture in Patients Undergoing Valve-in-Valve TAVR. JACC: Cardiovascular Interventions. 2023;16:530-539.
6. Shavadia JS, Stanberry L, Singh J, Thao KR, Ghasemzadeh N, Mercado N, Nayak KR, Alraies MC, Bagur R, Saw J, Bagai A, Bainey KR, Madan M, Amlani S, Garberich R, Grines CL, Garcia S, Henry TD, Dehghani P. Comparative Analysis of Patients With STEMI and COVID-19 Between Canada and the United States. J Soc Cardiovasc Angiogr Interv. 2023 Jun 21:100970. doi: 10.1016/j.jscai.2023.100970. Epub ahead of print. PMID: 37363317; PMCID: PMC10284462.
7. Kandzari, DE, Garcia-Garcia, HM, Stoler, RC, et al. Ultrathin bioresorbable polymer sirolimus-eluting stents in US patients undergoing coronary revascularization: 1-Year outcomes from the BIOFLOW VII trial. Catheter Cardiovasc Interv. 2023; 1- 8. doi:10.1002/ccd.30783
8. Patel SP, Garcia S, Sathananthan J, Tang GHL, Albaghdadi MS, Pibarot P, Cubeddu RJ. Structural Valve Deterioration in Transcatheter Aortic Bioprostheses: Diagnosis, Pathogenesis, and Treatment. Struct Heart. 2023 Apr 4;7(3):100155. doi: 10.1016/j.shj.2022.100155. PMID: 37273857; PMCID: PMC10236800.
9. Garcia S, Ye J, Webb J, Reardon M, Kleiman N, Goel S, Hatab T, Fam N, Peterson M, Liauw S, Frisoli TM, Bashir H, Paige D, Rock D, Schmidt C, Jollis JG and Kereiakes DJ. Transcatheter Treatment of Native Aortic Valve Regurgitation: The North American Experience With a Novel Device. JACC Cardiovasc Interv. 2023;16:1953-1960.
10. Mankerious, N., Megaly, M., Hemetsberger, R. et al. Short Versus Long-Term Dual Antiplatelet Therapy in Patients at High Bleeding Risk Undergoing PCI in Contemporary Practice: A Systemic Review and Meta-analysis. Cardiol Ther (2023). https://doi.org/10.1007/s40119-023-00318-5
11. Garcia S, Kereiakes D. Balloon Aortic Valvuloplasty in the Era of Transcatheter Valve Replacement. Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 101042
12. Garcia S, Dowling R, Chung E, et al. J-Valve Transcatheter Treatment of Native Valve Aortic Regurgitation Associated With a Left Ventricular Assist Device. Journal of the Society for Cardiovascular Angiography & Interventions 2 (2023) 101044
13. Han BK, Garcia S, Aboulhosn J et al. Technical recommendations for computed tomography guidance of intervention in the right ventricular outflow tract: Native RVOT conduits and bioprosthetic valves:: A white paper of the Society of Cardiovascular Computed Tomography (SCCT), Congenital Heart Surgeons' Society (CHSS), and Society for Cardiovascular Angiography & Interventions (SCAI). J Cardiovasc Comput Tomogr 2023.
14. Sharma RV, Laham RJ, Sorajja, P, Shah B, Garcia S, Jain R, Fender EA, Philip F, Eisenberg R, Popma JP, Chetcuti S. Echocardiographic and Clinical Outcomes in Symptomatic Patients with Less Than Severe Aortic Stenosis After Supra-Annular Self-Expanding Transcatheter Aortic Valve Replacement. American Journal of cardiology 2023 (208) 37-43. https://doi.org/10.1016/j.amjcard.2023.08.140.
15. Blusztein D, Sarwary S, Parikh DS, Garcia S, Price MJ, Nayak K, Aragon J and Mahadevan VS. Safety of Same-Day Hospital Discharge Post Patent Foramen Ovale Closure: Findings from a Multicenter Study. Am J Cardiol. 2023;208:118-123.
16. Sparrow RT, Sposato LA, Alkhouli MA, Garcia S, Elgendy IY, Kuchtaruk AA, Jneid H, Alraies MC, Tzemos N, Mamas MA and Bagur R. Readmissions After Left Atrial Appendage Closure in Patients With Previous Ischemic Stroke or Transient Ischemic Attack. CJC Open. 2023;5:950-964.
17. Quesada O, Yildiz M, Henry TD, Bergstedt S, Chambers J, Shah A, Stanberry L, Volpenhein L, Aziz D, Lantz R, Palmer C, Ugwu J, Ahsan MJ, Garberich RF, Rohm HS, Aguirre FV, Garcia S and Sharkey SW. Mortality in ST-Segment Elevation Myocardial Infarction With Nonobstructive Coronary Arteries and Mimickers. JAMA Network Open. 2023;6:e2343402-e2343402.
18. Garcia S, Elmariah S, Cubeddu RJ, Zahr F, Eleid MF, Kodali SK, Seshiah P, Sharma R and Lim DS. Mitral Transcatheter Edge-to-Edge Repair With the PASCAL Precision System: Device Knobology and Review of Advanced Steering Maneuvers. Struct Heart. 2024;8:100234.
19. Novel Lithotripsy-Assisted Transcatheter Aortic Valve Replacement May Reduce Risk of Aortic Root Rupture. JSCAI
20. Left Ventricular Hemodynamics with Veno-Arterial Extracorporeal Membrane Oxygenation. In press. CCI
21. Hashimoto G, Garcia S, Sato H, Fukui M, Hammadah M, Steffen R, Cavalcante JL and Bapat VN. New Insights and Perspective on Bioprosthetic Valve Fracture From Bench Testing and Computed Tomography Analysis. Structural Heart. 2024:100276.
22. Late Migration of a Transcatheter Heart Valve. JACC case report. In press.

23. Ahmed A, Alsidawi S, Bae R, Cavalcante J, Fukui M, Gossl M, Sorajja P and Garcia S. Changes in quality of life in patients with low-flow aortic stenosis undergoing transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2020.

24. Elbadawi A, Elgendy IY, Megaly M, Saad M, Garcia S, Abbott JD, Aronow H, Gafoor S, Jneid H and Sorajja P. Temporal Trends and Outcomes of Transcatheter Mitral Valve Repair Among Nonagenarians. JACC Cardiovasc Interv. 2020.

25. Anantha-Narayanan M, Malik U, Mbai M, Megaly M, Florea V, Sharma A, Cavalcante JL and Garcia S. Impact of diastolic dysfunction on long-term mortality and quality of life after transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2020;95:1034-1041.

26. Daniels MJ, Garcia S. Inspiring Resilience in the Pulmonary Position – Is a Paradigm Shift Due in Congenital Heart Disease? Structural Heart 2020:1-3.

27. Megaly M, Sorajja, P, Cavalcante J, Pershad A, Gossl M, Abraham B, Omer M, Elbadawi A, Garcia S.  Ischemic Stroke With Cerebral Protection System During Transcatheter Aortic Valve ReplacementJ Am Coll Cardiol Intv 2020;13:2149–55.

28. Bohm M, Kario K, Kandzari DE, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Konstantinidis D, Choi JW, East C, Lee DP, Ma A, Ewen S, Cohen DL, Wilensky R, Devireddy CM, Lea J, Schmid A, Weil J, Agdirlioglu T, Reedus D, Jefferson BK, Reyes D, D'Souza R, Sharp ASP, Sharif F, Fahy M, DeBruin V, Cohen SA, Brar S, Townsend RR and Investigators SH-OMP. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020;395:1444-1451.

29. Elbadawi A, Elgendy IY, Megaly M, Ugwu J, Shahin HI, Al-Azizi K, Garcia S, Abbott JD, Gafoor S, Kleiman NS and Goel SS. Trends and Outcomes of Transcatheter Aortic Valve Implantation Among Solid Organ Transplant Recipients. Am J Cardiol. 2021;138:122-124.

30. Hammadah M, Ponce C, Sorajja P, Cavalcante JL, Garcia S and Gossl M. Point-of-care ultrasound: Closing guideline gaps in screening for valvular heart disease. Clin Cardiol. 2020;43:1368-1375.

31. Megaly M, Han K, Sedhom R, Aboulhosn J, Moga F, Mudy K, Daniels MJ, Elbadawi A, Omer M, Mosleh W, Cavalcante JL and Garcia S. Outcomes of percutaneous and surgical pulmonary valve implantation. Cardiovasc Revasc Med. 2021

32. Megaly M, Sedhom R, Abdelmaseeh P, ElBebawy B, Goel SS, Karam J, Pershad A, Brilakis ES and Garcia S. Complications of the MANTA closure device. Insights from MAUDE database. Cardiovasc Revasc Med. 2021.

33. Lopes BBC, Sorajja P, Hashimoto G, Fukui M, Bapat VN, Du Y, Bae R, Schwartz RS, Stanberry LI, Enriquez-Sarano M, Garcia S, Lesser JR and Cavalcante JL. Tricuspid Anatomic Regurgitant Orifice Area by Functional DSCT: A Novel Parameter of Tricuspid Regurgitation Severity. JACC Cardiovasc Imaging. 2021.

34. Hammadah M, Han BK, de Oliveira Nunes M, Aboulhosn JA, Zahn EM, Babaliaros V, Daniels MJ, Cavalcante JL, Lesser JR and Garcia S. Hypoattenuated Leaflet Thickening After Transcatheter Pulmonary Valve Replacement With the SAPIEN 3 Valve. JACC Cardiovasc Imaging. 2021.

35. Guddeti RR, Pajjuru VS, Walters RW, Garcia S and Alla VM. Impact of gender on in-hospital mortality and 90-day readmissions in patients undergoing transcatheter edge-to-edge mitral valve repair: Analysis from the National Readmission Database. Catheter Cardiovasc Interv. 2021.

36. Shroff GR, Bangalore S, Bhave NM, Chang TI, Garcia S, Mathew RO, Rangaswami J, Ternacle J, Thourani VH, Pibarot P, American Heart Association Council on the Kidney in Cardiovascular D and Stroke C. Evaluation and Management of Aortic Stenosis in Chronic Kidney Disease: A Scientific Statement From the American Heart Association. Circulation. 2021;143:e1088-e1114.

37. Morcos R, Megaly M, Desai A, Alkhouli M, Saad M, Luna M, Garcia S, Khalili H and Maini B. The transseptal puncture experience: Safety insights from FDA MAUDE database. Catheter Cardiovasc Interv. 2021.

38. Hashimoto G, Cavalcante JL, Mooney MR, Burns MR, Ukaigwe AC and Garcia S. Assessment of aortic bioprosthetic valve fracture by Computed Tomography Angiography. J Cardiovasc Comput Tomogr. 2021;15:e7-e9.

39. Garcia S, Cubeddu RJ, Hahn RT, Ternacle J, Kapadia SR, Kodali SK, Thourani VH, Jaber WA, Asher CR, Elmariah S, Makkar R, Webb JG, Herrmann HC, Lu M, Devireddy CM, Malaisrie SC, Smith CR, Mack MJ, Sorajja P, Cavalcante JL, Goessl M, Shroff GR, Leon MB and Pibarot P. 5-Year Outcomes Comparing Surgical Versus Transcatheter Aortic Valve Replacement in Patients With Chronic Kidney Disease. JACC Cardiovasc Interv. 2021;14:1995-2005.

40. Du Y, Gossl M, Garcia S, Enriquez-Sarano M, Cavalcante JL, Bae R, Hashimoto G, Fukui M, Lopes B, Ahmed A, Schmidt C, Stanberry L, Garberich R, Bradley SM, Steffen R and Sorajja P. Natural history observations in moderate aortic stenosis. BMC Cardiovasc Disord. 2021;21:108.

41. In-hospital and Readmission Permanent Pacemaker Implantation After Transcatheter Aortic Valve Replacement. Megaly, M, Sedhom R, Elbadawi S, Saad M, Cavalcante, J, Sengupta J, Garcia S. Structural Heart Journal. In press.

42. Fukui M, Sorajja P, Hashimoto G, Lopes BBC, Stanberry LI, Garcia S, Gössl M, Cheng V, Enriquez-Sarano M, Bapat VN, Lesser JR and Cavalcante JL. Right ventricular dysfunction by computed tomography associates with outcomes in severe aortic stenosis patients undergoing transcatheter aortic valve replacement. J Cardiovasc Comput Tomogr. 2021.

43. Alperi A, Garcia S and Rodés-Cabau J. Transcatheter valve-in-valve implantation in degenerated surgical aortic and mitral bioprosthesis: Current state and future perspectives. Prog Cardiovasc Dis. 2021.

44. Garcia S, Fukui M, Dworak M, et al. Clinical Impact of Hypoattenuating Leaflet Thickening after Transcatheter Aortic Valve Replacement. Circulation CV Interventions 2022. Circ Cardiovasc Interv. 2022;15:e 011480. DOI:10.1161/CIRCINTERVENTIONS.121.011480

45. Morcos, R, Megaly M, Saad M, Garcia S, et al. In-Hospital Outcomes of Transesophageal versus Intracardiac Echocardiography Guided Left Atrial Appendage Closure. CCI 2022.

46. Sedhom R, Megaly M, Saad M, Elbadawi A, Witzke CF, Garcia S, Latib A and Gafoor SA. Transcatheter edge-to-edge repair of the tricuspid valve: The US experience. Catheter Cardiovasc Interv. 2022.

47. Association of Left Ventricular Remodeling Assessment by Cardiac Magnetic Resonance With Outcomes in Patients With Chronic Aortic Regurgitation. JAMA Cardiology

48. Miho Fukui, Vinayak Bapat, Santiago Garcia, Marshall Dworak, Go Hashimoto, Hirotomo Sato, Mario Gössl, Maurice Enriquez-Sarano, John Lesser, João Cavalcante, and Paul Sorajja. Deformation of Transcatheter Aortic Valve Prostheses: Implications for Hypo-Attenuating Leaflet Thickening and Clinical Outcomes. Circulation 2022.

49. Association Between Early Left Ventricular Ejection Fraction Improvement After Transcatheter Aortic Valve Replacement and 5-Year Clinical Outcomes: An Analysis of the PARTNER Trials and Registries. JAMA cardiology

50. KereiakesD, Garcia, S. Coronary Obstruction After Transcatheter Aortic Valve Replacement: FromRisk Prediction to Prevention. JSCAI