RecruitingTricuspid RegurgitationTricuspid Valve DiseaseTricuspid Valvular Disorders
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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).
Sponsor: VDyne, Inc.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ Patient anatomy (cardiac and vascular) is not suitable for VDyne System as assessed by Imaging Core Labs, Sponsor or Clinical Screening Committee (CSC)
- ✕ Intolerance to procedural anticoagulation or post-procedural antiplatelet/ anticoagulation regimen that cannot be medically managed
- ✕ Hypersensitivity to nickel or titanium
- ✕ Left Ventricular Ejection Fraction (LVEF) \<30%.
- ✕ Severe RV dysfunction.
- ✕ Significant abnormalities of the tricuspid valve and sub-valvular apparatus.
- ✕ Sepsis including active infective endocarditis (IE) (within last 6 months).
- ✕ Right ventricular, atrial thrombus, vegetation or mass on tricuspid valve.
Where it's recruiting
California
Los Angeles
Michigan
Detriot
Minnesota
Minneapolis · Rochester
New York
New York · The Bronx
Ohio
Cincinnati
Oregon
Portland
South Carolina
Charleston
Tennessee
Nashville
Source: ClinicalTrials.gov · NCT05848284 · last updated 2026-09-21