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The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System — SPACER  

Tricuspid Valve Regurgitation Clinical Trial

Official title:
The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System

Clinical Trial Summary

The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement.

Clinical Trial Description

The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement. The study is a multi-center, international, prospective, single arm, safety study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, 1 year and annually for 3 years post implant procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02787408
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date September 14, 2016
Completion date December 14, 2020
View Details
See also
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