TRISCEND II Pivotal Trial
Last updated on July 2021Recruitment
- 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