Actively Recruiting
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
Led by VDyne, Inc. · Updated on 2026-03-31
30
Participants Needed
11
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and clinical effects of the VDyne Transcatheter Tricuspid Valve Replacement System for treating people with symptomatic severe tricuspid regurgitation, a heart valve disorder. This study aims to assess how well the device works and its safety profile in improving symptoms and heart function in affected patients. The study involves implanting the VDyne system, which includes a bioprosthetic tricuspid valve and delivery tools, via a transfemoral approach while the heart is beating. The valve can be repositioned or retrieved during the procedure if needed. There is one treatment group receiving this device, and the procedure is guided by imaging techniques without the use of cardiopulmonary bypass. Participants will be monitored from the time of implant through one year after the procedure. Researchers will assess major adverse events, changes in valve function, symptom status, exercise capacity, and quality of life at various timepoints up to one year. Safety and effectiveness will be evaluated through imaging, clinical assessments, and questionnaires. The study starts with screening, implantation, and includes follow-up visits for ongoing evaluation.
CONDITIONS
Brief Title
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic severe tricuspid valve regurgitation of primary or secondary cause
- NYHA class II or higher; if NYHA Class IV, patient must be ambulatory
- Treated with medical therapy for heart failure including a diuretic for at least 30 days before the procedure
- Recommended candidate for the VDyne System by Heart Team
- Age over 18 years at the time of procedure
- Suitability for treatment confirmed by Clinical Screening Committee and Imaging Core Labs
You will not qualify if you...
- Cardiac or vascular anatomy unsuitable for VDyne System
- Intolerance to anticoagulation or antiplatelet therapy that cannot be managed
- Allergic to nickel or titanium
- Left ventricular ejection fraction below 30%
- Severe right ventricular dysfunction
- Significant tricuspid valve or sub-valvular abnormalities
- Active or recent infection including sepsis or infective endocarditis
- Right heart thrombus, vegetation, or mass on tricuspid valve
- Severe calcification of tricuspid valve annulus or leaflets
- Pulmonary hypertension with systolic pressure over 70 mmHg
- History of rheumatic fever
- Significant coronary artery disease requiring treatment
- Planned surgery or intervention within 30 days before or after implant
- Severe carotid stenosis over 70%
- Recent cardiac device implantation or permanent pacing leads interfering with valve delivery
- Cardiogenic shock or instability requiring support at implant
- Prior tricuspid valve surgery or device that prevents VDyne implantation
- Other significant valvular heart disease needing intervention
- Intracardiac shunt such as septal defect
- Stroke or TIA within 6 months
- Severe lung disease or need for continuous oxygen or steroids
- Recent heart attack within 30 days
- Severe kidney dysfunction or dialysis
- Advanced liver disease
- Recent bleeding requiring transfusion
- Clotting disorders that cannot be managed
- Chronic immunosuppression or conditions impairing healing
- Blood disorders such as anemia or coagulopathy
- Unwillingness to receive blood products
- Allergies to procedural medications not manageable
- Life expectancy under 12 months due to other illnesses
- Treatment expected to be futile
- Current intravenous drug use or recent abuse
- Pregnant, breastfeeding, or planning pregnancy within 12 months
- Vulnerable populations such as minors or cognitively impaired
- Participation in other investigational trials that interfere
- Unable or unwilling to provide informed consent or comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - 1 day (procedure day)
Participants receive the VDyne Transcatheter Tricuspid Valve Replacement System implanted via a transfemoral approach while the heart remains beating.
1 procedure visit (in-person)
Duration - Up to 1 year after implant
Participants are monitored for safety and effectiveness of the device, including assessments of heart function and symptoms.
Approximately 1 month follow-up visit and additional visits up to 1 year
Trial Site Locations
Total: 11 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
2
Henry Ford Hospital
Detriot, Michigan, United States, 48208
Actively Recruiting
3
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
4
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
Actively Recruiting
6
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
7
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
8
Oregon Health and Science Unversity
Portland, Oregon, United States, 97239
Actively Recruiting
9
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
10
Ascension St. Thomas
Nashville, Tennessee, United States, 37205
Actively Recruiting
11
Québec-Université Laval (IUCPQ-ULaval)
Québec, Quebec, Canada, G1V 4G5
Actively Recruiting
Research Team
V
Vinny Podichetty
J
Jeya Satheesh
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here