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Mitral-valve-disease

Mitral Valve Disease

Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous etiologies. 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.

Note: paragraph extracted from MVARC Part 2, available through the link below.

ARC Publications

Mitral Academic Research Consortium (MVARC-1-Part 1): Design Principles

• 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 (MVARC-1 Part 1, 2015).
Reference: Eur Heart J. 2015 Aug 1;36(29):1851-77

 

• 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 (MVARC-1 Part 1, 2015).
Reference: J Am Coll Cardiol. 2015 Jul 21;66(3):278-307.

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Mitral Academic Research Consortium (MVARC-1-Part 2): Endpoint Definitions

• Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions A Consensus Document From the Mitral Valve Academic Research Consortium (MVARC-1, Part 2, 2015).
Reference: Eur Heart J. 2015 Aug 1;36(29):1878-91.

 

• Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions A Consensus Document From the Mitral Valve Academic Research Consortium (MVARC-1, Part 2, 2015).
Reference: J Am Coll Cardiol. 2015 Jul 21;66(3):308-321.

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Other relevant references

Percutaneous Mitral Valve Repair With the MitraClip in Primary Compared With Secondary Mitral Valve Regurgitation Using the Mitral Valve Academic Research Consortium Criteria.

Reference: J Invasive Cardiol. 2017 Apr;29(4):145-150.

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Transcatheter implantation of aortic valve prostheses into degenerated mitral valve bioprostheses and failed annuloplasty rings: outcomes according to access route and Mitral Valve Academic Research Consortium (MVARC) criteria.

Reference: EuroIntervention. 2016 Dec 20;12(12):1520-1526.

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Mitral Valve Academic Research Consortium Consensus Report: The U.S. Food and Drug Administration Perspective.

Reference: J Am Coll Cardiol. 2015 Jul 21;66(3):322-323.

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Mitral Valve Academic Research Consortium consensus report: the U.S. Food and Drug Administration perspective.

Reference: Eur Heart J. 2015 Aug 1;36(29):1849-50.

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