TRIPLACE Registry for Transcatheter Tricuspid Valve Replacement
This study is a global registry, called TRIPLACE, for people undergoing Transcatheter Tricuspid Valve Replacement (TTVR). TTVR is a procedure where a new valve is placed in your heart without open-heart surgery, to treat tricuspid regurgitation (a condition where the tricuspid valve doesn't close properly). The goal is to learn more about the safety and effectiveness of TTVR, including potential complications like needing a pacemaker. You may be able to join if you are 18 or older and are having TTVR for native tricuspid valve disease. The study will look at how many people have device-related complications and how much their tricuspid regurgitation improves 30 days after the procedure. The current recruitment status is unclear, and the study plans to include 800 participants.
- Study design
- This is an observational study, meaning researchers will collect information from 800 participants who are already undergoing a specific procedure. It is not a randomized trial.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures outcomes at 30 days after the procedure, but long-term outcomes are also being examined.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
At a glance
Conditions
Where it's being run
21 sites across 13 statesStudy leadership
- Andrea Scotti, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center
- Azeem Latib, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center
- Rishi Puri, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic
- Neil Fam, MD · PRINCIPAL_INVESTIGATOR · St. Michaels Hospital
- Thomas Modine, MD · PRINCIPAL_INVESTIGATOR · University Hospital, Bordeaux
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Freedom from device-related complications30 days after the index procedure
Freedom from device-related complications will be determined by assessing the number of participants with procedural, peri-procedural and device-related complications
- Reduction in Tricuspid Regurgitation Severity30 days after the index procedure
Tricuspid Regurgitation measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Tricuspid Regurgitation is measured by transthoracic echocardiography in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Change from baseline tricuspid regurgitation severity score 30 days after baseline will be assessed