Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
NCT ID: NCT05848284
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-04-01
2030-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VDyne System Treatment Arm
Device
VDyne Transcatheter Tricuspid Valve Replacement System
The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System which consists of a bioprosthetic implantable tricuspid valve, the VDyne Delivery System, Drop Tether, accessories that facilitate the placement of the valve and the VDyne Retrieval System. The VDyne Valve is deployed by transfemoral implantation within the native tricuspid valve and is implanted under fluoroscopic and transesophageal echocardiography (TEE) guidance, while the heart remains beating, without the use of CPB. The valve is repositionable and fully retrievable intraoperatively. Repositioning allows optimization of the valve position following deployment, and retrieval, with the VDyne Retrieval System, allows use of an alternative valve size or removal of the index VDyne Valve in the event of suboptimal valve delivery or other intraoperative complication.
Interventions
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VDyne Transcatheter Tricuspid Valve Replacement System
The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System which consists of a bioprosthetic implantable tricuspid valve, the VDyne Delivery System, Drop Tether, accessories that facilitate the placement of the valve and the VDyne Retrieval System. The VDyne Valve is deployed by transfemoral implantation within the native tricuspid valve and is implanted under fluoroscopic and transesophageal echocardiography (TEE) guidance, while the heart remains beating, without the use of CPB. The valve is repositionable and fully retrievable intraoperatively. Repositioning allows optimization of the valve position following deployment, and retrieval, with the VDyne Retrieval System, allows use of an alternative valve size or removal of the index VDyne Valve in the event of suboptimal valve delivery or other intraoperative complication.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
* Bleeding requiring transfusion within prior 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 (Hgb \< 9), thrombocytopenia, history of bleeding diathesis, or coagulopathy.
* Unwilling to receive blood products.
* 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 within next 12 months.
* 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 enrollment.
* Patient unable or unwilling to comply with study required testing and follow-up visits
18 Years
ALL
No
Sponsors
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VDyne, Inc.
INDUSTRY
Responsible Party
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Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
Henry Ford Hospital
Detriot, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Oregon Health and Science Unversity
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Ascension St. Thomas
Nashville, Tennessee, United States
Québec-Université Laval (IUCPQ-ULaval)
Québec, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Dominique Lachance Clinical Study Coordinator
Role: primary
Related Links
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Related Info
Other Identifiers
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TPR0037-P
Identifier Type: -
Identifier Source: org_study_id
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