Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
VDyne, Inc.
Summary
The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Symptomatic severe tricuspid valve regurgitation of primary or secondary etiology. * NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory. * Subject is adequately treated with medical therapy for heart failure ≥ 30 days prior to * index procedure, including a diuretic. * Heart Team determines patient is a recommended candidate for the VDyne System. * Age \>18 years at time of index procedure. * Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System. Exclusion Criteria: * Patient anatomy (cardiac and vas…