VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation
VDyne, Inc.
Summary
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
Description
The clinical trial is a prospective, multi-center, randomized controlled pivotal trial to evaluate the safety and effectiveness of the VDyne Transcatheter Tricuspid Valve Replacement (TTVR) System compared to Edwards EVOQUE TTVR System in symptomatic patients with severe or greater tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥18 years old * Subject is willing and able to comply with all study evaluations and provide consent * Subject must agree not to participate in any other clinical trial for a period of one year following index procedure * New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory * At least severe symptomatic tricuspid regurgitation. * Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR * Heart team determines that the subject is appropriate for transcathete…
Interventions
- DeviceTranscatheter Tricuspid Valve Replacement (TTVR) with VDyne System
Subjects will undergo TTVR procedure with VDyne device and will continue to be managed on Optimal Medical Therapy (OMT).
- DeviceTranscatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System
Subjects will undergo TTVR procedure with Edwards EVOQUE device and will continue to be managed on Optimal Medical Therapy (OMT).
Location
- Minneapolis Heart Institute FoundationMinneapolis, Minnesota