Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
Purpose
This clinical trial evaluates the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in symptomatic patients with severe or greater tricuspid regurgitation.
Condition
- Severe Tricuspid Regurgitation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- Any tricuspid device currently in place. - Anatomic contraindications. - Need for emergent or urgent surgery. - Left ventricular ejection fraction <25%.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Medtronic Intrepid™ TTVR |
Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation. |
|
|
Active Comparator Edwards EVOQUE TTVR |
Transcatheter tricuspid valve replacement with Edwards EVOQUE TTVR in patients with severe or greater tricuspid regurgitation. |
|
|
Experimental Single Arm Registry |
Transcatheter tricuspid valve replacement with Medtronic Intrepid™ TTVR System in patients with severe or greater tricuspid regurgitation who are not eligible for randomization. |
|
Recruiting Locations
Abrazo Arizona Heart Hospital
Phoenix, Arizona 85016
Phoenix, Arizona 85016
Los Robles Hospital & Medical Center
Thousand Oaks, California 91360
Thousand Oaks, California 91360
Abbott Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
The Christ Hospital
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
More Details
- Status
- Recruiting
- Sponsor
- Medtronic Cardiovascular
Detailed Description
Prospective, global, pre-market, interventional, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation.