Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis

Carlos E. Ruiz, Rebecca T. Hahn, Alain Berrebi, Jeffrey S. Borer, Donald E. Cutlip, Greg Fontana, Gino Gerosa, Reda Ibrahim, Vladimir Jelnin, Hasan Jilaihawi, E. Marc Jolicoeur, Chad Kliger, Itzhak Kronzon, Jonathon Leipsic, Francesco Maisano, Xavier Millan, Patrick Nataf, Patrick T. O'Gara, Philippe Pibarot, Stephen R. RameeCharanjit S. Rihal, Josep Rodes-Cabau, Paul Sorajja, Rakesh Suri, Julie A. Swain, Zoltan G. Turi, E. Murat Tuzcu, Neil J. Weissman, Jose L. Zamorano, Patrick W. Serruys, Martin B. Leon

Research output: Contribution to journalReview article

8 Citations (Scopus)

Abstract

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.

Original languageEnglish (US)
Pages (from-to)1224-1245
Number of pages22
JournalEuropean Heart Journal
Volume39
Issue number15
DOIs
StatePublished - Apr 14 2018

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Prostheses and Implants
Clinical Trials
Research
Equipment and Supplies
Surgical Instruments
Safety

Keywords

  • closure devices
  • regurgitation
  • transcatheter

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Ruiz, C. E., Hahn, R. T., Berrebi, A., Borer, J. S., Cutlip, D. E., Fontana, G., ... Leon, M. B. (2018). Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis. European Heart Journal, 39(15), 1224-1245. https://doi.org/10.1093/eurheartj/ehx211

Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis. / Ruiz, Carlos E.; Hahn, Rebecca T.; Berrebi, Alain; Borer, Jeffrey S.; Cutlip, Donald E.; Fontana, Greg; Gerosa, Gino; Ibrahim, Reda; Jelnin, Vladimir; Jilaihawi, Hasan; Jolicoeur, E. Marc; Kliger, Chad; Kronzon, Itzhak; Leipsic, Jonathon; Maisano, Francesco; Millan, Xavier; Nataf, Patrick; O'Gara, Patrick T.; Pibarot, Philippe; Ramee, Stephen R.; Rihal, Charanjit S.; Rodes-Cabau, Josep; Sorajja, Paul; Suri, Rakesh; Swain, Julie A.; Turi, Zoltan G.; Tuzcu, E. Murat; Weissman, Neil J.; Zamorano, Jose L.; Serruys, Patrick W.; Leon, Martin B.

In: European Heart Journal, Vol. 39, No. 15, 14.04.2018, p. 1224-1245.

Research output: Contribution to journalReview article

Ruiz, CE, Hahn, RT, Berrebi, A, Borer, JS, Cutlip, DE, Fontana, G, Gerosa, G, Ibrahim, R, Jelnin, V, Jilaihawi, H, Jolicoeur, EM, Kliger, C, Kronzon, I, Leipsic, J, Maisano, F, Millan, X, Nataf, P, O'Gara, PT, Pibarot, P, Ramee, SR, Rihal, CS, Rodes-Cabau, J, Sorajja, P, Suri, R, Swain, JA, Turi, ZG, Tuzcu, EM, Weissman, NJ, Zamorano, JL, Serruys, PW & Leon, MB 2018, 'Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis', European Heart Journal, vol. 39, no. 15, pp. 1224-1245. https://doi.org/10.1093/eurheartj/ehx211
Ruiz, Carlos E. ; Hahn, Rebecca T. ; Berrebi, Alain ; Borer, Jeffrey S. ; Cutlip, Donald E. ; Fontana, Greg ; Gerosa, Gino ; Ibrahim, Reda ; Jelnin, Vladimir ; Jilaihawi, Hasan ; Jolicoeur, E. Marc ; Kliger, Chad ; Kronzon, Itzhak ; Leipsic, Jonathon ; Maisano, Francesco ; Millan, Xavier ; Nataf, Patrick ; O'Gara, Patrick T. ; Pibarot, Philippe ; Ramee, Stephen R. ; Rihal, Charanjit S. ; Rodes-Cabau, Josep ; Sorajja, Paul ; Suri, Rakesh ; Swain, Julie A. ; Turi, Zoltan G. ; Tuzcu, E. Murat ; Weissman, Neil J. ; Zamorano, Jose L. ; Serruys, Patrick W. ; Leon, Martin B. / Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis. In: European Heart Journal. 2018 ; Vol. 39, No. 15. pp. 1224-1245.
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