RECRUITING

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

Conditions

Tricuspid Regurgitation Tricuspid Valve Disease Tricuspid Valvular Disorders VDyne

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-04-01

Study Completion:2030-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05848284

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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). * 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

Inclusion Criteria

Exclusion Criteria

* 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.

* 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).
* 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

Contacts and Locations

Study Contact

Jeya Satheesh

CONTACT

+1.952.686.8158

jsatheesh@vdyne.com

Study Locations (Sites)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407

United States

Mayo Clinic - Rochester

Rochester, Minnesota, 55905

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Ascension St. Thomas

Nashville, Tennessee, 37205

United States

Collaborators and Investigators

Sponsor: VDyne, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-01

Study Completion Date2030-11-30

Study Record Updates

Study Start Date2024-04-01

Study Completion Date2030-11-30

Terms related to this study

Keywords Provided by Researchers

VDyne

Additional Relevant MeSH Terms

Tricuspid Regurgitation
Tricuspid Valve Disease
Tricuspid Valvular Disorders