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Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Tricuspid Valve Regurgitation Clinical Trial

Official title:
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Clinical Trial Summary

The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.

Clinical Trial Description

The early feasibility study of the Edwards FORMA Tricuspid Transcatheter Repair System is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System. Data collected in this clinical study will include safety and function of the investigational system as well as up to 3 year clinical outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02471807
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date December 2015
Completion date January 17, 2023
View Details
See also
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