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Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) — SCOUT-II  

Heart Valve Disease Clinical Trial

Official title:
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation

Clinical Trial Summary

The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation.

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. The study will include up to 60 subjects from up to 15 sites in Europe and the United States. Follow-up evaluations will be conducted through 5 years post implantation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03225612
Study type Interventional
Source Mitralign, Inc.
Contact Patricia Keating
Phone 978-863-2445
Email pkeating@mitralign.com
Status Recruiting
Phase N/A
Start date May 22, 2017
Completion date November 2022
View Details
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