TRICAV-I Study for Severe Tricuspid Regurgitation
This study is testing a new device called the TricValve® Transcatheter Bicaval Valve System for people with severe tricuspid regurgitation (a heart condition where the tricuspid valve doesn't close properly, causing blood to flow backward). The TricValve system involves placing two valves, one in the superior vena cava (SVC) and one in the inferior vena cava (IVC), which are large veins near your heart. The goal is to see if this system is safe and effective in improving outcomes for patients who are at high risk for traditional tricuspid valve surgery. To join, you must be 18 or older, have severe tricuspid regurgitation, and experience significant heart failure symptoms. The study will look at important outcomes like mortality (death) and stroke at 1 month and 12 months after the procedure.
- Study design
- This is a multicenter clinical study planning to enroll 50 participants. It is designed to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System.
- What's involved
- You would receive the TricValve System and then be closely followed for 12 months. Long-term safety and effectiveness data will be collected annually for up to 5 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed up closely for 12 months after the intervention. Long-term safety and efficacy data will be collected annually up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)
At a glance
Conditions
NCT06137807
Where you'd take part
This study runs at 36 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
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
Chicago Advocate Christ
Palos Park, Illinoisno site contact published
Cleveland Clinic
Cleveland, Ohiono site contact published
Delray Medical Center
Delray Beach, Floridano site contact published
Duke Cardiology Clinic
Durham, North Carolinano 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.
Study leadership
- Katharina Kiss, MD · STUDY_CHAIR · Products & Features GmbH
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Mortality1 Month and 12 Months
Number of days until death
- Stroke1 Month
Number of days until death
- Pulmonary Embolism1 Month
Number of days until death
- Valve Academic Research Consortium (VARC) type 2-4 bleeding complication1 Month
Number of days until death
- Major vascular, access-related, or cardiac structural complication1 Month
Number of days until death
- Stage 3 Acute Kidney Injury with increase in serum creatinine >300% (>3.0x increase) and/or serum creatinine ≥4.0mg/dL (≥354 μmol/L) with an acute increase of ≥ 0.5 mg/dL (≥44 μmol/L)7 Days
Number of days from baseline until increase
- Stage 4 Acute Kidney Injury requiring new temporary or permanent renal replacement therapy1 Month
Number of days until new renal replacement therapy
- Emergency surgery or intervention related to the device/procedure complications1 Month
Number of days until emergency surgery or intervention
- Right Ventricular Assist Device (RVAD) implantation or heart transplant12 Months
Number of days until Right Ventricular Assist Device (RVAD) implantation or heart transplant
- Tricuspid valve surgery or percutaneous tricuspid intervention12 Months
Number of days until tricuspid valve surgery or percutaneous tricuspid intervention
- Heart Failure Events12 Months
Number of heart failure episodes including hospitalization, or worsening heart failure
- Kansas City Cardiomyopathy Questionnaire (KCCQ) Score12 Months
Change in KCC score (score ranges between 0 and 100)
- New York Heart Association (NYHA class)12 Months
Change in NYHA class (range from I to IV)
- Six Minute Walking Test (6MWT)12 Months
Change in walking distance