Actively Recruiting
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
Led by VDyne, Inc. · Updated on 2026-03-31
30
Participants Needed
11
Research Sites
399 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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
- New York Heart Association (NYHA) class II or higher; if NYHA class IV, patient must be ambulatory
- Receiving medical therapy for heart failure including diuretics for at least 30 days before the procedure
- Determined suitable candidate for the VDyne System by the Heart Team
- Age over 18 years at time of procedure
- Clinical and imaging confirmation of suitability for VDyne System treatment
You will not qualify if you...
- Anatomy not suitable for VDyne System implantation as assessed by experts
- Cannot tolerate anticoagulation or antiplatelet treatment related to the procedure
- Allergy to nickel or titanium
- Left ventricular ejection fraction less than 30%
- Severe right ventricular dysfunction
- Significant abnormalities of the tricuspid valve or surrounding structures
- Active or recent (within 6 months) infection including infective endocarditis
- Presence of right heart clots or masses on the tricuspid valve
- Severe calcification of the tricuspid valve ring or leaflets
- Pulmonary artery pressure over 70 mmHg
- History of rheumatic fever
- Significant coronary artery disease needing treatment
- Planned surgery or interventions within 30 days before or after implant
- Severe carotid artery narrowing over 70%
- Recent cardiac device implantation within 60 days
- Permanent pacemaker leads interfering with valve delivery
- Cardiogenic shock or unstable condition needing support at procedure time
- Prior tricuspid valve surgery or device that blocks VDyne implantation
- Other significant valve diseases requiring intervention
- Known intracardiac shunts
- Stroke or transient ischemic attack within 6 months
- Severe lung disease needing oxygen or steroids
- Heart attack within 30 days
- Severe kidney dysfunction or dialysis
- Advanced liver disease
- Recent bleeding needing transfusion
- Clotting disorders not manageable medically
- Chronic immunosuppression or poor healing conditions
- Blood disorders or unwillingness to accept blood products
- Allergy to procedure medications or contrast agents
- Life expectancy under 12 months due to other diseases
- Treatment considered futile
- Current intravenous drug use or use within past year
- Pregnant, breastfeeding, or planning pregnancy within 12 months
- Vulnerable groups like minors, cognitively impaired, prisoners, or employees with potential coercion
- Participation in another investigational trial that may interfere
- Unable or unwilling to give informed consent or comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jeya Satheesh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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