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Tests treatment safety and results for Tricuspid Regurgitation
Official title Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US)
ClinicalTrials.gov ID: NCT05848284
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join if
- Patient anatomy (cardiac and vascular) is not suitable for VDyne System as assessed by Imaging Core Labs, Sponsor or Clinical Screening Committee...
- 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.
See the full eligibility 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 treatment 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Detriot, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- The Bronx, New York, United States
- Cincinnati, Ohio, United States
- Portland, Oregon, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Detriot, Michigan, United States; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States; New York, New York, United States; The Bronx, New York, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.