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

Heart Valve Disease Clinical Trial

Official title:
Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02574650
Study type Interventional
Source Mitralign, Inc.
Contact Gisella Blanchette
Phone 978-863-2435
Email gblanchette@mitralign.com
Status Recruiting
Phase N/A
Start date November 2015
Completion date May 2019
View Details
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