IRB Study Number 23-554
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
This study is designed as a prospective, global, multicenter, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE system with medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation
Inclusion Criteria
- Despite medical therapy (OMT) per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. Patient must be on OMT per the local heart team at the time of TR assessment for trial eligibility (TTE). OMT includes stable oral diuretic medications, unless patient has a documented history of intolerance
- Functional and/or degenerative TR graded as at least severe on a transthoracic echocardiogram (assessed by the echo core lab)
- The Local Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
- All other inclusion criteria will be assessed by study staff
Exclusion Criteria
- Poor RV function
- Prior annuloplasty ring implant
- Infiltrative cardiomyopathy or valvulopathy
- All other exclusion criteria will be assessed by study staff
