Last updated on July 2017

Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign .


Brief description of study

The purpose of this study is to assess the early safety and performance of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR). The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.

Detailed Study Description

A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation and whom left-sided valve surgery is not planned. The study will include up to 30 subjects from up to 6 sites. Follow-up evaluations will be conducted through 2-years post implantation.

Clinical Study Identifier: NCT02574650

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Saibal Kar, MD

Cedars-Sinai Medical Center
Los Angeles, CA United States
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Lowell Satler, MD

MedStar Washington Hospital Center
Washington, D.C., United States
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Brijeshwar Maini, MD

Delray Medical Center
Delray Beach, FL United States
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Christopher Meduri, MD

Piedmont Healthcare
Atlanta, GA United States
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Stuart Rich, MD

Northwestern University / Bluhm Cardiovascular Institute
Chicago, IL United States
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Rebecca Hahn, MD

Columbia University Medical Center / New York-Presbyterian Hospital
New York, NY United States
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Scott Lim, MD

University of Virginia
Charlottesville, VA United States
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