Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles A Consensus Document from the Mitral Valve Academic Research Consortium
Gregg W. Stone,Alec Vahanian,David H. Adams,William T. Abraham,Jeffrey S. Borer,Jeroen J. Bax,Joachim Schofer,Donald E. Cutlip,Mitchell W. Krucoff,Eugene H. Blackstone,Philippe Généreux,Michael J. Mack,Robert J. Siegel,Paul A. Grayburn,Maurice Enriquez-Sarano,Patrizio Lancellotti,Gerasimos Filippatos,Arie Pieter Kappetein +17 more
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TL;DR: A 2-part document describing consensus recommendations for clinical trial design and endpoint definitions to guide evaluation of transcatheter and surgical therapies for MR is described.
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About: This article is published in Journal of the American College of Cardiology. The article was published on 21 Jul 2015. and is currently open access. The article focuses on the topics: Mitral valve & Mitral regurgitation.
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Citations
Transcatheter Mitral Valve Replacement for Patients With Symptomatic Mitral Regurgitation: A Global Feasibility Trial
David W.M. Muller,Robert S. Farivar,Paul Jansz,Richard Bae,Darren L. Walters,Andrew Clarke,Paul A. Grayburn,Robert C. Stoler,Gry Dahle,Kjell Arne Rein,Marty Shaw,Gregory M. Scalia,Mayra Guerrero,Paul J. Pearson,Samir R. Kapadia,Marc Gillinov,Augusto D. Pichard,Paul J. Corso,Jeffrey J. Popma,Michael Chuang,Philipp Blanke,Jonathon Leipsic,Paul Sorajja,Tendyne Global Feasibility Trial Investigators +23 more
TL;DR: Transcatheter mitral valve replacement (TMVR) is an effective and safe therapy for selected patients with symptomatic native MR and may help address an unmet need in patients at high risk for cardiac surgery.
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Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study
Fabien Praz,Konstantinos Spargias,Michael Chrissoheris,Lutz Büllesfeld,Georg Nickenig,Florian Deuschl,Robert Schueler,Neil Fam,Robert Moss,Moody Makar,Robert H. Boone,Jeremy Edwards,Aris Moschovitis,Saibal Kar,John G. Webb,Ulrich Schäfer,Ted Feldman,Stephan Windecker +17 more
TL;DR: This study establishes feasibility of the Edwards PASCAL TMVr system with a high rate of technical success and reduction of mitral regurgitation severity, and further research is needed on procedural and long-term clinical outcomes.
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Definitions and Clinical Trial Design Principles for Coronary Artery Chronic Total Occlusion Therapies: CTO-ARC Consensus Recommendations.
Luiz F. Ybarra,Stéphane Rinfret,Emmanouil S. Brilakis,Dimitri Karmpaliotis,Lorenzo Azzalini,J. Aaron Grantham,David E. Kandzari,Kambis Mashayekhi,James C. Spratt,Harindra C. Wijeysundera,Ziad A. Ali,Christopher E. Buller,Mauro Carlino,David Cohen,Donald E. Cutlip,Tony De Martini,Carlo Di Mario,Andrew Farb,Aloke V Finn,Alfredo R. Galassi,C. Michael Gibson,Colm G. Hanratty,Jonathan Hill,Farouc A. Jaffer,Mitchell W. Krucoff,William Lombardi,Akiko Maehara,P. F.Adrian Magee,Roxana Mehran,Jeffrey W. Moses,William J. Nicholson,Yoshinobu Onuma,Yoshinobu Onuma,Georgios Sianos,Satoru Sumitsuji,Etsuo Tsuchikane,Renu Virmani,Simon J Walsh,Gerald S. Werner,Masahisa Yamane,Gregg W. Stone +40 more
TL;DR: The Chronic Total Occlusion Academic Research Consortium (CTRAC) as discussed by the authors is a broad consortium comprising academicians, practicing physicians, researchers, medical society representatives, and regulators (US Food and Drug Administration) to develop methods, end points, biomarkers, parameters, data, materials, processes, procedures, evaluations, tools and techniques for CTO interventions.
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Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings.
Sung Han Yoon,Brian Whisenant,Sabine Bleiziffer,Victoria Delgado,Niklas Schofer,Lena Eschenbach,Buntaro Fujita,Rahul Sharma,Marco Ancona,Ermela Yzeiraj,Stefano Cannata,Colin MacLeod Barker,James E. Davies,Antonio H. Frangieh,Florian Deuschl,Tomaz Podlesnikar,Masahiko Asami,Abhijeet Dhoble,Anthony C. Chyou,Jean Bernard Masson,Harindra C. Wijeysundera,Daniel J. Blackman,Rajiv Rampat,Maurizio Taramasso,Enrique Gutiérrez-Ibañes,Tarun Chakravarty,Guiherme F. Attizzani,Tsuyoshi Kaneko,S. Chiu Wong,Horst Sievert,Fabian Nietlispach,David Hildick-Smith,Luis Nombela-Franco,Lenard Conradi,Christian Hengstenberg,Michael J. Reardon,Albert M. Kasel,Simon Redwood,Antonio Colombo,Saibal Kar,Francesco Maisano,Stephan Windecker,Thomas Pilgrim,Stephan Ensminger,Bernard Prendergast,Joachim Schofer,Ulrich Schaefer,Jeroen J. Bax,Azeem Latib,Raj Makkar +49 more
TL;DR: In this paper, the authors evaluated the outcomes of transcatheter mitral valve replacement in patients with failed mitral bioprosthetic valves (ViV) and annuloplasty rings (valve-in-ring [ViR]).
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Initial Feasibility Study of a New Transcatheter Mitral Prosthesis: The First 100 Patients
Paul Sorajja,Neil Moat,Vinay Badhwar,Darren L. Walters,Gaetano Paone,Brian Bethea,Richard Bae,Gry Dahle,Mubashir Mumtaz,Paul A. Grayburn,Samir R. Kapadia,Vasilis C. Babaliaros,Mayra Guerrero,Lowell F. Satler,Vinod H. Thourani,Francesco Bedogni,David G. Rizik,Paolo Denti,Nicolas Dumonteil,Thomas Modine,Ajay Sinhal,Michael L Chuang,Jeffrey J. Popma,Philipp Blanke,Jonathon Leipsic,David W.M. Muller +25 more
TL;DR: In this study of TMVR, which is the largest experience to date, the prosthesis was highly effective in relieving MR and improving symptoms, with an acceptable safety profile.
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