VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation
New heart valve study for severe leaky tricuspid valves begins recruitment soon.
Plain English Summary
VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial) is a Not Applicable clinical trial sponsored by VDyne, Inc. studying Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases, Tricuspid Valve Insufficiency, Severe Heart Valve Disease, Randomized Controlled Trial (RCT), Symptomatic Tricuspid Regurgitation. This study tests a new device to replace a leaky tricuspid heart valve without open-heart surgery. It is for patients with severe tricuspid valve regurgitation who have symptoms despite medical treatment. Participation involves a procedure to implant the new valve and regular follow-up visits. Alternatives include medical management, surgery to repair or replace the valve, or other less invasive procedures. The trial aims to enroll 730 participants.
Official Summary
Pivotal trial to evaluate the safety and clinical efficacy of the VDyne System for the treatment of symptomatic severe or greater tricuspid regurgitation.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with severe tricuspid valve regurgitation causing symptoms. Patients must be able to comply with study requirements and have a heart team determine they are suitable for this procedure. Individuals with certain other severe heart valve problems, recent stroke, severe lung disease, or certain blood disorders may not be eligible. This trial is studying Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases, Tricuspid Valve Insufficiency, Severe Heart Valve Disease, Randomized Controlled Trial (RCT), Symptomatic Tricuspid Regurgitation, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will measure how safe the new valve is by tracking major complications and how well it works by looking at improvements in daily function and quality of life. The specific primary outcome measures are: Composite of major adverse events (MAEs) (30 days post-procedure); Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention (12 months post-procedure); Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) (12 months post procedure); Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA) (12 months post procedure). 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 patients with severe tricuspid valve regurgitation, offering a less invasive treatment option when medical therapy is insufficient. This research targets Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases, Tricuspid Valve Insufficiency, Severe Heart Valve Disease, Randomized Controlled Trial (RCT), Symptomatic Tricuspid Regurgitation, where improved treatment options are needed.
Investor Insight
This trial is a pivotal study for a novel transcatheter tricuspid valve replacement system, indicating a significant market opportunity in treating a common and often debilitating heart valve conditio The large enrollment target of 730 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if your symptoms are due to severe tricuspid valve leakage and if this study might be an option for you. Be prepared for a procedure to implant the valve and regular check-ups for up to two years to monitor your health and the valve's performance. Understand that you will be randomly assigned to receive either the new VDyne valve or another approved valve system. The trial is being conducted at multiple 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: RANDOMIZED
- Model: PARALLEL
- Masking: SINGLE
- Enrollment: 730 participants
Interventions
- DEVICE: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System — Subjects will undergo TTVR procedure with VDyne device and will continue to be managed on Optimal Medical Therapy (OMT).
- DEVICE: Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System — Subjects will undergo TTVR procedure with Edwards EVOQUE device and will continue to be managed on Optimal Medical Therapy (OMT).
Primary Outcomes
- Composite of major adverse events (MAEs) (30 days post-procedure)
- Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention (12 months post-procedure)
- Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) (12 months post procedure)
- Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA) (12 months post procedure)
Secondary Outcomes
- All-Cause Mortality (At 12 months and 24 months)
- RVAD implantation or heart transplant (At 12 months and 24 months)
- Tricuspid valve surgical or percutaneous intervention (At 12 months and 24 months)
- Heart failure hospitalizations (At 12 months and 24 months)
- Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) (At 12 months and 24 months)
Full Eligibility Criteria
Inclusion Criteria: * Age ≥18 years old * Subject is willing and able to comply with all study evaluations and provide consent * Subject must agree not to participate in any other clinical trial for a period of one year following index procedure * New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory * At least severe symptomatic tricuspid regurgitation. * Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR * Heart team determines that the subject is appropriate for transcatheter tricuspid valve replacement * Functional and/or degenerative TR graded as at least severe Exclusion Criteria: * Subject unable or unwilling to comply with study required testing and follow-up visits * Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study * Pregnant, lactating subjects, and /or those who plan pregnancy in the period up to one year following index procedure. * Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically * Life expectancy ≤12 months due to non-cardiac comorbidities * Current IV Drug user (must be free from drug abuse for ≥1 year) * Subject unable or unwilling to provide written, informed consent before study enrollment * Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System * Hypersensitivity to metals (such as nickel or titanium) * 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.) * Severe valvular heart disease using established echocardiographic criteria requiring intervention other than the tricuspid valve * Known significant intracardiac shunt (e.g., septal defect). * Cerebrovascular accident (stroke, TIA) within 90 days of treatment procedure * Severe lung disease (severe COPD) or continuous use of home oxygen or oral steroids * Acute myocardial infarction (AMI) within 30 days of SSC determination of eligibility * Leukopenia, chronic anemia (Hgb \< 9 g/dL), current thrombocytopenia (platelets \<70/mcL), history of bleeding diathesis, or coagulopathy * Unwilling to receive blood products * Deep vein thrombosis and/or pulmonary embolism in the last 6-months
Frequently Asked Questions
What is clinical trial NCT07516444?
NCT07516444 is a Not Applicable INTERVENTIONAL study titled "VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)." It is currently not yet recruiting and is sponsored by VDyne, Inc.. The trial targets enrollment of 730 participants.
What conditions does NCT07516444 study?
This trial investigates treatments for Tricuspid Valve Regurgitation, Tricuspid Valve Disease, Cardiovascular Diseases (CVD), Heart Valve Diseases, Tricuspid Valve Insufficiency, Severe Heart Valve Disease, Randomized Controlled Trial (RCT), Symptomatic Tricuspid Regurgitation. The primary condition under study is Tricuspid Valve Regurgitation.
What treatments are being tested in NCT07516444?
The interventions being studied include: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne System (DEVICE), Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System (DEVICE). Subjects will undergo TTVR procedure with VDyne device and will continue to be managed on Optimal Medical Therapy (OMT).
What does Not Applicable mean for NCT07516444?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07516444?
This trial is currently "Not Yet Recruiting." It started on 2026-06. The estimated completion date is 2036-06.
Who is sponsoring NCT07516444?
NCT07516444 is sponsored by VDyne, Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07516444?
The trial aims to enroll 730 participants. The trial has not yet started recruiting.
How is NCT07516444 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT07516444?
The primary outcome measures are: Composite of major adverse events (MAEs) (30 days post-procedure); Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention (12 months post-procedure); Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) (12 months post procedure); Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA) (12 months post procedure). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07516444?
The official record for NCT07516444 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07516444. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07516444 testing in simple terms?
This study tests a new device to replace a leaky tricuspid heart valve without open-heart surgery. It is for patients with severe tricuspid valve regurgitation who have symptoms despite medical treatment.
Why is this trial significant?
This trial addresses a significant unmet need for patients with severe tricuspid valve regurgitation, offering a less invasive treatment option when medical therapy is insufficient.
What are the potential risks of participating in NCT07516444?
Potential risks include bleeding, stroke, heart attack, or the need for another procedure to fix or replace the new valve. Some patients may experience allergic reactions to medications or materials used during the procedure. There is a risk that the new valve may not function perfectly or could require future intervention. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07516444?
Ask your doctor if your symptoms are due to severe tricuspid valve leakage and if this study might be an option for you. Be prepared for a procedure to implant the valve and regular check-ups for up to two years to monitor your health and the valve's performance. Understand that you will be randomly assigned to receive either the new VDyne valve or another approved valve system. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07516444 signal from an investment perspective?
This trial is a pivotal study for a novel transcatheter tricuspid valve replacement system, indicating a significant market opportunity in treating a common and often debilitating heart valve conditio This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves a procedure to implant the new valve and regular follow-up visits. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.