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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.

To access, purchase, authenticate, or subscribe to the full-text of this article, please visit this link: http://dx.doi.org/10.1016/j.jacc.2015.05.046 Byline: Gregg W. Stone, MD [gs2184@columbia.edu] (*,[Dagger],*), Alec S. Vahanian, MD ([double dagger]), David H. Adams, MD (s.), William T. Abraham,... Full description

Journal Title: Journal of the American College of Cardiology Vol.66(3), pp.278-307
Main Author: Stone, Gregg W
Other Authors: Vahanian, Alec S , Adams, David H , Abraham, William T , Borer, Jeffrey S , Bax, Jeroen J , Schofer, Joachim , Cutlip, Donald E , Krucoff, Mitchell W , Blackstone, Eugene H , Généreux, Philippe , Mack, Michael J , Siegel, Robert J , Grayburn, Paul A , Enriquez-Sarano, Maurice , Lancellotti, Patrizio , Filippatos, Gerasimos , Kappetein, Arie Pieter , Stone, Gregg W
Format: Electronic Article Electronic Article
Language: English
Subjects:
Created: July 21, 2015
ID: E-ISSN: 1558-3597 ; DOI: 10.1016/j.jacc.2015.05.046
Link: http://search.proquest.com/docview/1697219959/?pq-origsite=primo
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title: 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.
format: Article
creator:
  • Stone, Gregg W
  • Vahanian, Alec S
  • Adams, David H
  • Abraham, William T
  • Borer, Jeffrey S
  • Bax, Jeroen J
  • Schofer, Joachim
  • Cutlip, Donald E
  • Krucoff, Mitchell W
  • Blackstone, Eugene H
  • Généreux, Philippe
  • Mack, Michael J
  • Siegel, Robert J
  • Grayburn, Paul A
  • Enriquez-Sarano, Maurice
  • Lancellotti, Patrizio
  • Filippatos, Gerasimos
  • Kappetein, Arie Pieter
  • Stone, Gregg W
subjects:
  • Cardiac Catheterization–Methods
  • Clinical Trials As Topic–Adverse Effects
  • Disease Management–Instrumentation
  • Echocardiography–Methods
  • Endpoint Determination–Surgery
  • Europe–Diagnosis
  • Heart Valve Prosthesis Implantation–Etiology
  • Humans–Physiopathology
  • Mitral Valve–Surgery
  • Mitral Valve Insufficiency–Methods
  • Patient Selection–Methods
  • Prognosis–Methods
  • Research Design–Methods
  • Risk Assessment–Methods
  • United States–Methods
  • Ventricular Remodeling–Methods
  • Abridged
  • Heart Failure
  • Mitral Regurgitation
  • Mitral Valve
  • Valve Intervention
  • Valve Surgery (or Cardiac Surgery)
ispartof: Journal of the American College of Cardiology, Vol.66(3), pp.278-307
description: To access, purchase, authenticate, or subscribe to the full-text of this article, please visit this link: http://dx.doi.org/10.1016/j.jacc.2015.05.046 Byline: Gregg W. Stone, MD [gs2184@columbia.edu] (*,[Dagger],*), Alec S. Vahanian, MD ([double dagger]), David H. Adams, MD (s.), William T. Abraham, MD (||), Jeffrey S. Borer, MD ([paragraph]), Jeroen J. Bax, MD, PhD (#), Joachim Schofer, MD (**), Donald E. Cutlip, MD ([Dagger][Dagger]), Mitchell W. Krucoff, MD ([double dagger][double dagger]), Eugene H. Blackstone, MD (s.s.), Philippe Genereux, MD (*,[Dagger],||||), Michael J. Mack, MD ([paragraph][paragraph]), Robert J. Siegel, MD (##), Paul A. Grayburn, MD ([paragraph][paragraph]), Maurice Enriquez-Sarano, MD (***), Patrizio Lancellotti, MD, PhD ([Dagger][Dagger][Dagger]), Gerasimos Filippatos, MD ([double dagger][double dagger][double dagger]), Arie Pieter Kappetein, MD, PhD (s.s.s.) for the Mitral Valve Academic Research Consortium (MVARC) Key Words heart failure; mitral regurgitation; mitral valve; valve intervention; valve surgery (or cardiac surgery) Abstract Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous etiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodeling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of transcatheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial desi
language: eng
source:
identifier: E-ISSN: 1558-3597 ; DOI: 10.1016/j.jacc.2015.05.046
fulltext: fulltext
issn:
  • 15583597
  • 1558-3597
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titleClinical 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.
creatorStone, Gregg W ; Vahanian, Alec S ; Adams, David H ; Abraham, William T ; Borer, Jeffrey S ; Bax, Jeroen J ; Schofer, Joachim ; Cutlip, Donald E ; Krucoff, Mitchell W ; Blackstone, Eugene H ; Généreux, Philippe ; Mack, Michael J ; Siegel, Robert J ; Grayburn, Paul A ; Enriquez-Sarano, Maurice ; Lancellotti, Patrizio ; Filippatos, Gerasimos ; Kappetein, Arie Pieter ; Stone, Gregg W
contributorStone, Gregg W (correspondence author) ; Stone, Gregg W (record owner)
creationdateJuly 21, 2015
ispartofJournal of the American College of Cardiology, Vol.66(3), pp.278-307
identifierE-ISSN: 1558-3597 ; DOI: 10.1016/j.jacc.2015.05.046
subjectCardiac Catheterization–Methods ; Clinical Trials As Topic–Adverse Effects ; Disease Management–Instrumentation ; Echocardiography–Methods ; Endpoint Determination–Surgery ; Europe–Diagnosis ; Heart Valve Prosthesis Implantation–Etiology ; Humans–Physiopathology ; Mitral Valve–Surgery ; Mitral Valve Insufficiency–Methods ; Patient Selection–Methods ; Prognosis–Methods ; Research Design–Methods ; Risk Assessment–Methods ; United States–Methods ; Ventricular Remodeling–Methods ; Abridged ; Heart Failure ; Mitral Regurgitation ; Mitral Valve ; Valve Intervention ; Valve Surgery (or Cardiac Surgery)
languageeng
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descriptionTo access, purchase, authenticate, or subscribe to the full-text of this article, please visit this link: http://dx.doi.org/10.1016/j.jacc.2015.05.046 Byline: Gregg W. Stone, MD [gs2184@columbia.edu] (*,[Dagger],*), Alec S. Vahanian, MD ([double dagger]), David H. Adams, MD (s.), William T. Abraham, MD (||), Jeffrey S. Borer, MD ([paragraph]), Jeroen J. Bax, MD, PhD (#), Joachim Schofer, MD (**), Donald E. Cutlip, MD ([Dagger][Dagger]), Mitchell W. Krucoff, MD ([double dagger][double dagger]), Eugene H. Blackstone, MD (s.s.), Philippe Genereux, MD (*,[Dagger],||||), Michael J. Mack, MD ([paragraph][paragraph]), Robert J. Siegel, MD (##), Paul A. Grayburn, MD ([paragraph][paragraph]), Maurice Enriquez-Sarano, MD (***), Patrizio Lancellotti, MD, PhD ([Dagger][Dagger][Dagger]), Gerasimos Filippatos, MD ([double dagger][double dagger][double dagger]), Arie Pieter Kappetein, MD, PhD (s.s.s.) for the Mitral Valve Academic Research Consortium (MVARC) Key Words heart failure; mitral regurgitation; mitral valve; valve intervention; valve surgery (or cardiac surgery) Abstract Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous etiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodeling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of transcatheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives. Abbreviations and Acronyms FDA, U.S. Food and Drug Administration; GDMT, guideline-directed medical therapy; LA, left atrial; LV, left ventricular; LVEF, left ventricular ejection fraction; MR, mitral regurgitation; MV, mitral valve; MVARC, Mitral Valve Academic Research Consortium; TEE, transesophageal echocardiography; TTE, transthoracic echocardiography Author Affiliation: (*) Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York ([Dagger]) Cardiovascular Research Foundation, New York, New York ([double dagger]) Hopital Bichat, Paris, France (s.) Mount Sinai Health System, New York, New York (||) The Ohio State University, Columbus, Ohio ([paragraph]) SUNY Downstate Medical Center, Brooklyn, New York (#) Leiden University Medical Center, Leiden, the Netherlands (**) Hamburg University Cardiovascular Center, Hamburg, Germany ([Dagger][Dagger]) Beth Israel Deaconess Medical Center, Boston, Massachusetts ([double dagger][double dagger]) Duke University Medical Center, Durham, North Carolina (s.s.) Cleveland Clinic, Cleveland, Ohio (||||) Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada ([paragraph][paragraph]) Baylor University Medical Center, Dallas, Texas (##) Cedars-Sinai Medical Center, Los Angeles, California (***) Mayo Clinic, Rochester, Minnesota ([Dagger][Dagger][Dagger]) University Hospital of Liege, Liege, Belgium ([double dagger][double dagger][double dagger]) Athens University Hospital Attikon, Athens, Greece (s.s.s.) Erasmus University Medical Center, Rotterdam, the Netherlands * Reprint requests and correspondence: Dr. Gregg W. Stone, Columbia University Medical Center, Cardiovascular Research Foundation, 111 East 59th Street, 11th Floor, New York, New York 10022. Article History: Received 5 March 2015; Revised 5 May 2015; Accepted 21 May 2015 (footnote) For complete information on the MVARC members and participants, please see the Online Appendix. The MVARC initiative was funded by unrestricted grant support from Abbott Vascular, Boston Scientific, Cardiac Dimensions, Cordis, Edwards Lifesciences, Guided Delivery Systems Inc., Mitralign, Medtronic, and Valtech. Dr. Stone has served as a consultant for AGA Medical, AstraZeneca, Atrium, Boston Scientific, Cardiovascular Systems, Inc., Eli Lilly/Daiichi Sankyo, InfraReDx, InspireMD, Miracor, Osprey, Reva, TherOx, Thoratec, Velomedix, and Volcano; and has equity in the Biostar and MedFocus family of funds, Caliber, Guided Delivery Systems, MiCardia, and Vascular Nanotransfer Technologies. Dr. Vahanian has received personal fees from Abbott Vascular, Edwards Lifesciences, and Valtech; has served as a consultant for Abbott Vascular and Valtech; and has received honoraria from Edwards Lifesciences. Dr. Adams has received royalties for intellectual property paid to his medical institution from Edwards Lifesciences and Medtronic. Dr. Abraham has served as a consultant for Abbott Vascular, Novartis, and St. Jude Medical/CardioMEMS; and was coprincipal investigator for the COAPT trial of MitraClip sponsored by Abbott Vascular. Dr. Borer has served as a consultant for Amgen, ARMGO, BioMarin, Boehringer Ingelheim, Celgene, Cleveland BioLabs, JenaValve, Salix, Sanofi, and Servier; and serves as a committee member for Cardiorentis, Celladon, the National Heart, Lung, and Blood Institute, Novartis, Pfizer, Somahlution, and Takeda USA. Dr. Cutlip has received research support from Medtronic, Boston Scientific, and Abbott Vascular. Dr. Krucoff has received grants and personal fees from and served as a consultant for Abbott Vascular, Boston Scientific, and Medtronic. Dr. Blackstone has received grants from Edwards Lifesciences. Dr. Genereux has received grants from Cardiac Dimensions, Inc.; and serves as a consultant/speaker for Abbott Vascular, Cardiovascular Systems, Inc., and Edwards Lifesciences. Dr. Mack has served as a coprincipal investigator of trials on transcatheter mitral valve replacement and MitraClip therapy. Dr. Grayburn has served as a consultant for Abbott Vascular, Bracco Diagnostics, and Tendyne Holdings; has received grants from Abbott Vascular, Edwards Lifesciences, Guided Delivery Systems, Medtronic, Tendyne Holdings, and Valtech Cardio; has received personal fees from Abbott Vascular, Bracco Diagnostics, and Tendyne Holdings; and has served as a consultant to Tendyne Holdings. Dr. Filippatos has received grants from Abbott Vascular; and serves as a committee member or principal investigator of trials sponsored by Bayer, Cardiorentis, European Union, Medtronic, and Novartis. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Saibal Kar, MD, served as Guest Editor for this paper. (footnote) Listen to this manuscript's audio summary by JACC Editor-in-Chief Dr. Valentin Fuster(https://s3.amazonaws.com/ADFJACC/JACC6603/JACC6603_fustersummary_07).
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titleClinical 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.
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titleClinical 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.
authorStone, Gregg W ; Vahanian, Alec S ; Adams, David H ; Abraham, William T ; Borer, Jeffrey S ; Bax, Jeroen J ; Schofer, Joachim ; Cutlip, Donald E ; Krucoff, Mitchell W ; Blackstone, Eugene H ; Généreux, Philippe ; Mack, Michael J ; Siegel, Robert J ; Grayburn, Paul A ; Enriquez-Sarano, Maurice ; Lancellotti,...
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6Heart Valve Prosthesis Implantation–Etiology
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btitleJournal of the American College of Cardiology
atitleClinical 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.
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