Study Purpose: This study is testing a new way to fix a heart valve problem using a special device called the Intrepid TTVR system. This device helps replace a damaged heart valve without major surgery, using a procedure that goes through a vein in your leg.
Patient Criteria: The study is looking for patients who have symptoms despite taking heart medicine, have a high risk of surgery, and have severe issues with their tricuspid valve, a part of the heart that controls blood flow. Patients must be able to use the Intrepid system and agree to attend follow-up visits.
Exclusions: Patients with certain other health problems, like a life expectancy of less than two years, severe heart muscle issues, or other heart blockages, cannot join the study.
- Study involves multiple locations and is not randomized.
- Participants need to attend all follow-up visits after the procedure.
- Patients cannot have serious non-heart health problems that lower life expectancy.