This study is in progress, not accepting new patients

New Investigational Device Study for Tricuspid Valve Replacement

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a study on Tricuspid Valve Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease Heart Valve Disease Cardiovascular Disease Heart Failure

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCSF
Dates
study started
completion around

Description

Summary

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Official Title

Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device

Details

The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Keywords

Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease, Heart Valve Diseases, Cardiovascular Diseases, Heart Failure, Edwards EVOQUE System, Optimal Medical Therapy, Edwards EVOQUE System & OMT

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT04482062
Study Type
Interventional
Participants
Expecting 1070 study participants
Last Updated