What is the Purpose of this Study?
The purpose of this study is to evaluate the safety and effectiveness of an experimental device called the Medtronic Intrepid TTVR system in patients with severe symptomatic tricuspid valve regurgitation whose doctor has recommended that they receive a new heart valve. Tricuspid valve regurgitation (a leaking tricuspid heart valve) occurs when the tricuspid valve does not close as it should, and blood flows backwards into the heart. The Medtronic Intrepid TTVR system is made of animal tissue attached to a metal frame. The valve is placed within the leaking tricuspid valve without open heart surgery and prevents blood from flowing backward. Participants will be enrolled into 1 of 3 study groups: Randomized, Single Arm, or Roll-in group. In the Randomized group, patients will be randomly assigned to receive 1 of 2 devices: the Medtronic Intrepid Transcatheter Tricuspid Valve Replacement System or the Edwards EVOQUE Tricuspid Valve Replacement System. The Edwards System is approved by the U.S. Food and Drug Administration (FDA) device for use in patients with severe or greater tricuspid valve regurgitation. In the Single Arm Group, participants will only receive the Medtronic study device. Participants in the Roll-In Group will also only receive the Medtronic study device.
Eligibility
- * Age ≥18 years at the time of consent.
- * Severe symptomatic tricuspid regurgitation (TR) despite optimal medical therapy (OMT).
- * Local site multidisciplinary heart team experienced in tricuspid valve therapies agrees that the subject is appropriate for TTVR.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Transcatheter Tricuspid Valve Replacement using the Medtronic Intrepid? TTVR System in patients with Severe Symptomatic Tricuspid Regurgitation