Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)

Recruiting now · Not applicable

Conditions studied: Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders

In brief

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).

Key facts

Study ID

NCT05848284

Run by

VDyne, Inc.

People needed

30

Starts

2024-04-01

Expected to finish

2031-11-30

Last updated by the study team

2026-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Severe tricuspid annular or leaflets calcification.
• Systolic pulmonary hypertension with systolic pulmonary artery pressure >70 mmHg.
• History or rheumatic fever
• Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease.
• Any planned surgery or interventional procedure within 30 days prior to or 30 days following the implant procedure. This includes any planned concomitant cardiovascular procedure such as CABG, PCI, pulmonary vein ablation, left atrial appendage occlusion, septal defect repair, etc.
• Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
• Cardiac resynchronization therapy device or implantable pulse generator implanted within 60 days of planned implant procedure.
• Permanent pacing leads that will interfere with delivery or implantation of the VDyne Valve.
• Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices at the time of planned implant procedure.
• 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.).
• Significant valvular heart disease requiring intervention other than the tricuspid valve.
• Known significant intracardiac shunt (e.g. septal defect)
• Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure.
• Severe lung disease (severe COPD or continuous use of home oxygen or oral steroids).
• Acute myocardial infarction (AMI) within 30 days.
• Significant renal dysfunction (eGFR<30 ml/min/1.73m2) or on dialysis.
• End-stage liver disease (MELD > 11 / CHILD class C).

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Henry Ford Hospital — Detriot, Michigan, United States (enrolling)
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic - Rochester — Rochester, Minnesota, United States (enrolling)
• Columbia University Medical Center/NYPH — New York, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)
• The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• Oregon Health and Science Unversity — Portland, Oregon, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Ascension St. Thomas — Nashville, Tennessee, United States (enrolling)
• Québec-Université Laval (IUCPQ-ULaval) — Québec, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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