Recruitment

Recruitment Status
Recruiting

Summary

Conditions
  • Cardiovascular Diseases
  • Heart Failure
  • Heart Valve Diseases
  • Tricuspid Valve Disease
  • Tricuspid Valve Insufficiency
  • Tricuspid Valve Regurgitation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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 fo...

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.

Tracking Information

NCT #
NCT04482062
Collaborators
Not Provided
Investigators
Principal Investigator: James Gammie, MD Johns Hopkins Health System Principal Investigator: Rebecca Hahn, MD Columbia University Principal Investigator: Susheel Kodali, MD Columbia University