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

VDyne

Status

Enrolling

Conditions

Tricuspid Valvular Disorders

Tricuspid Valve Disease

Tricuspid Regurgitation

Treatments

Device: VDyne Transcatheter Tricuspid Valve Replacement System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05797519

TPR0038-P

Details and patient eligibility

About

The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Severe or greater 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 or older at time of the index procedure.
Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.

Exclusion criteria

VDYNE SYSTEM SUITABILITY

Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs, Sponsor and/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

CLINICAL EXCLUSION CRITERIA (assessed by pre-procedural imaging)
Left Ventricular Ejection Fraction (LVEF) <30%
Severe RV dysfunction as assessed by the Clinical Screening Committee (CSC).
Significant abnormalities of the tricuspid valve and sub-valvular apparatus
Sepsis including active infective endocarditis (IE) (within the 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 or pulmonary vascular resistance (PVR) >5 wood units as determined by RHC.
History of rheumatic fever that impacts the native tricuspid valve or surrounding structures.

CONCOMITANT PROCEDURES
Significant coronary artery disease requiring treatment such as symptomatic, unresolved multi-vessel or unprotected left main coronary artery disease (CAD).
Any planned surgery or interventional procedure within 30 days prior to or following the implant procedure. This includes any planned concomitant cardiovascular procedure [e.g. Coronary Artery Bypass Grafting (CABG), percutaneous coronary intervention (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), patent foramen ovales (PFOs) without significant shunts are allowed]

COMORBIDITIES
Cerebrovascular accident (stroke, TIA) within 6 months of treatment procedure
Severe lung disease [severe chronic obstructive pulmonary disease (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 and Child-Pugh class C)
Bleeding requiring transfusion within 30 days
Coagulopathy or other clotting disorder that cannot be medically managed
Chronic immunosuppression or other condition that could impair healing response
Any of the following: leukopenia, chronic anemia [Hemoglobin (Hgb) < 9], current thrombocytopenia (platelets <70), history of bleeding diathesis, or coagulopathy
Unwilling to receive blood products GENERAL EXCLUSION CRITERIA
Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution) which cannot be adequately managed medically
Life expectancy less than 12 months due to non-cardiac comorbidities
Treatment is not expected to provide benefit (futile)
Current IV Drug user (must be free drug abuse for > 1 year)
Pregnant, lactating or planning pregnancy during the course of the study
Vulnerable patient groups (minors, cognitively impaired persons, prisoners, persons whose willingness to volunteer could be unduly influenced by the expectation of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate, such as students, residents, and employees)
Currently participating in an investigational drug or device trial that has not reached its primary endpoint or is likely to interfere with this study
Patient (or legal guardian) unable or unwilling to provide written informed consent before study-specific procedures are conducted
Patient unable or unwilling to comply with study required testing and follow-up visits.