Transcatheter Tricuspid Valve Replacement Using the Medtronic Intrepid™ TTVR System in Patients With Severe Symptomatic Tricuspid Regurgitation - PATHFINDER
Medtronic Cardiovascular
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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%.
Interventions
- DeviceMedtronic Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) System
Transcatheter Tricuspid Valve Replacement
- DeviceEdwards EVOQUE Tricuspid Valve Replacement (TTVR) System
Transcatheter Tricuspid Valve Replacement
Locations (4)
- Abrazo Arizona Heart HospitalPhoenix, Arizona
- Los Robles Hospital & Medical CenterThousand Oaks, California
- Abbott Northwestern HospitalMinneapolis, Minnesota
- The Christ HospitalCincinnati, Ohio