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

Plain English Summary

Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US) is a Not Applicable clinical trial sponsored by VDyne, Inc. studying Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders. This trial tests a new device called the VDyne Transcatheter Tricuspid Valve Replacement System to treat severe leaky tricuspid valves. It is for adults with symptomatic severe tricuspid regurgitation who are recommended for this treatment by a heart team. Participation involves receiving the new valve through a catheter-based procedure and attending follow-up appointments. Alternatives may include medical therapy, other surgical valve repair or replacement, or no treatment depending on individual circumstances. The trial aims to enroll 30 participants.

Official Summary

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).

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults over 18 years old with severe tricuspid regurgitation causing symptoms. Patients must be medically stable and have tried other heart failure treatments. Individuals with certain heart conditions like very low ejection fraction, severe right ventricle dysfunction, or specific valve abnormalities cannot participate. Those with recent infections, blood clots, severe lung or kidney disease, or certain other medical conditions are also excluded. This trial is studying Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures will show how safe the new valve system is by tracking major complications within 30 days and how well it improves the leakage of the tricuspid valve, symptoms, and daily The specific primary outcome measures are: The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC). (Implant to 30 days post-procedure); Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs (Baseline to 1 month after implant); Changes in symptom status (NYHA class) (Baseline to 1 month after implant); Changes in functional capacity (6-minute walk test) (Baseline to 1 month after implant); Changes in in quality of life (KCCQ score) (Baseline to 1 month after implant). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses a significant unmet need for less invasive treatment options for patients suffering from severe tricuspid regurgitation, a condition that can lead to heart failure and reduced qua This research targets Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders, where improved treatment options are needed.

Investor Insight

This trial signals a significant investment in transcatheter valve technology, targeting the large and growing market for structural heart disease interventions, with a high probability of success if

Is This Trial Right for Me?

Ask your doctor if this new valve system is a suitable option for you and what the risks and benefits are compared to other treatments. Understand that participation involves a procedure to implant the valve and regular follow-up visits to monitor your progress. Be prepared for potential follow-up tests like echocardiograms and exercise tests to assess the valve's function and your overall health. This trial is currently recruiting participants. The trial is being conducted at 11 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 30 participants

Interventions

• 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, wi

Primary Outcomes

• The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC). (Implant to 30 days post-procedure)
• Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs (Baseline to 1 month after implant)
• Changes in symptom status (NYHA class) (Baseline to 1 month after implant)
• Changes in functional capacity (6-minute walk test) (Baseline to 1 month after implant)
• Changes in in quality of life (KCCQ score) (Baseline to 1 month after implant)

Secondary Outcomes

• The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) after 30 days to 1 year of the procedure, as classified by the Clinical Events Committee (CEC). (30 days post-procedure to 1 year)
• Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs (1 month after implant to 1 year post-implant)
• Changes in right ventricle as measured by core lab (1 month after implant to 1 year post-implant)
• Rate of heart failure hospitalization (1 month after implant to 1 year post-implant)
• Changes in symptom status (NYHA class) (1 month after implant to 1 year post-implant)

Full Eligibility Criteria

Inclusion 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.

Exclusion Criteria:

* 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

Trial Locations

• Cedars-Sinai Medical Center, Los Angeles, 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
• The Christ Hospital, Cincinnati, Ohio, 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
• ...and 1 more locations

Frequently Asked Questions

Related Conditions

• Tricuspid Regurgitation
• Tricuspid Valve Disease
• Tricuspid Valvular Disorders
• Heart Failure
• Pulmonary Hypertension
• Congestive Heart Failure
• Cardiovascular Diseases
• Valvular Heart Disease
• Cardiac Arrhythmia
• Arrhythmia

More Tricuspid Regurgitation Trials

View all Tricuspid Regurgitation clinical trials