Transcatheter Tricuspid Valve Replacement With the Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System in Severe Tricuspid Regurgitation
NCT07321899 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1186
Last updated 2026-01-08
Summary
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.
Conditions
- Severe Tricuspid Regurgitation
Interventions
- DEVICE
-
Medtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System
Transcatheter Tricuspid Valve Replacement
- DEVICE
-
Edwards EVOQUE Tricuspid Valve Replacement (TTVR) System
Transcatheter Tricuspid Valve Replacement
Sponsors & Collaborators
-
Medtronic Cardiovascular
lead INDUSTRY
Principal Investigators
-
Vinayak N. Bapat, MD · Minneapolis Heart Institute
-
Anita Asgar, MD · Northwestern Medicine Bluhm Cardiovascular Institute
-
Nicolas Dumonteil, MD · Clinique Pasteur Groupe CardioVasculaire Interventionnel
-
Azeem Latib, MD · Montefiore Medical Center
-
Firas Zahr, MD · Knight Cardiovascular Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2031-09-30
- Completion
- 2041-04-30
- FDA Device
- Yes
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