TricValve System for Severe Tricuspid Regurgitation
This study is testing a new device called the TricValve System for people with severe tricuspid regurgitation (a heart condition where a valve doesn't close properly, causing blood to flow backward). The study will compare the TricValve System along with standard medical care to standard medical care alone. Researchers want to see if the TricValve System can improve how well your heart works, your quality of life, and your ability to walk. They will also track any major side effects. You might be able to join if you are between 18 and 85 years old and have severe tricuspid regurgitation and caval reflux (blood flowing backward into the large veins leading to the heart). The study is currently recruiting participants.
- Study design
- This is a randomized study, meaning participants are assigned by chance to receive either the TricValve System plus medical therapy or medical therapy alone. The study plans to enroll 780 participants.
- What's involved
- Participants will have follow-up visits at discharge, 1 month, 30 days, 3 months, 6 months, 12 months, and annually for up to 5 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 5 years after treatment to monitor their health and the effectiveness of the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation.
At a glance
Conditions
NCT06458907
Where you'd take part
This study runs at 34 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Ascension Medical Group St. Vincent The Heart Center of Indiana
Indianapolis, Indianano site contact published
Baylor Scott & White Medical
Plano, Texasno site contact published
Beth Israel Deaconess Medical Center
Boston, Massachusettsno site contact published
Cardiovascular Institute of the South
Houma, Louisianano site contact published
Carilion Clinic
Roanoke, Virginiano site contact published
Cleveland Clinic
Cleveland, Ohiono site contact published
Delray Medical Center
Delray Beach, Floridano site contact published
Endeavor Health
Glenview, Illinoisno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Randomized Cohort: Caval Reflux (CR) grade reduction6 months
Reduction in Caval Reflux (CR) assessed by the echocardiography core laboratory. The CR will be assessed using the 3-grade scale: Grade 1 (no reflux, reflux extending for less than 1 cm below the diaphragm), Grade 2 ( reflux extending for less than 3 cm), Grade 3 (reflux of 3 cm or more). Lower grades of CR are better.
- Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement6 months
Comparison of clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm.
- Randomized Cohort: Rate of Major Adverse Events (MAE)30 days
Rate of Major Adverse Events (MAE) in experimental arm (TricValve + OMT)
- Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve surgery or percutaneous tricuspid intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improv1 year
Comparison of clinical outcomes using a single hierarchical analysis. Treatment effect will be summarized using Win Ratio statistics, where a value greater than 1 indicates improved outcomes in the experimental group compared with the comparator arm.
- Registry Cohort: Rate of Major Adverse Events (MAE)30 days
Rate of Major Adverse Events (MAE) in single arm registry