Overview
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
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 transcatheter tricuspid valve replacement
- Functional and/or degenerative TR graded as at least severe
Exclusion Criteria:
- Subject unable or unwilling to comply with study required testing and follow-up visits
- Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study
- Pregnant, lactating subjects, and /or those who plan pregnancy in the period up to one year following index procedure.
- Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically
- Life expectancy ≤12 months due to non-cardiac comorbidities
- Current IV Drug user (must be free from drug abuse for ≥1 year)
- Subject unable or unwilling to provide written, informed consent before study enrollment
- Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System
- Hypersensitivity to metals (such as nickel or titanium)
- Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne valve (e.g., valve replacement, edge to edge repair, etc.)
- Severe valvular heart disease using established echocardiographic criteria requiring intervention other than the tricuspid valve
- Known significant intracardiac shunt (e.g., septal defect).
- Cerebrovascular accident (stroke, TIA) within 90 days of treatment procedure
- Severe lung disease (severe COPD) or continuous use of home oxygen or oral steroids
- Acute myocardial infarction (AMI) within 30 days of SSC determination of eligibility
- Leukopenia, chronic anemia (Hgb \< 9 g/dL), current thrombocytopenia (platelets \<70/mcL), history of bleeding diathesis, or coagulopathy
- Unwilling to receive blood products
- Deep vein thrombosis and/or pulmonary embolism in the last 6-months
