RecruitingTricuspid Valve RegurgitationTricuspid Valve DiseaseCardiovascular Diseases (CVD)
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
Sponsor: VDyne, Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Minnesota
Minneapolis
Source: ClinicalTrials.gov · NCT07516444 · last updated 2026-08-17