IRB Study Number 26-403
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The purpose of the PATHFINDER study is to evaluate the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in patients with severe, symptomatic tricuspid regurgitation. The Medtronic Intrepid™ TTVR System, called the study device throughout this document, is investigational, which means it is not approved by the U.S. Food and Drug Administration (FDA).
Inclusion Criteria
- The local Heart Team determines that the patient is appropriate for TTVR.
- Functional and/or degenerative TR graded as at least severe on a TTE.
- Despite OMT per the local Heart Team, patient has signs of TR, symptoms from TR, or prior HF hospitalizations from TR. Patient must be on OMT per the local Heart Team at the time of TR assessment (TTE) for trial eligibility. OMT includes stable oral diuretic medications, unless patient has a documented history of intolerance.
Exclusion Criteria
- Stroke within the last 90 days.
- Co-morbid condition(s) that, in the opinion of the investigator, limit life expectancy to <12 months (365 days).
- Currently participating in another investigational biologic, drug or device study.
