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.

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NCT06033274

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

Recruiting
Not specifiedAges 18+Observational
Montefiore Medical Center
~800 participants
Updated 2025-09-10 on ClinicalTrials.gov
What's tested:Transcatheter Tricuspid Valve Replacement

At a glance

Recruiting sites
20 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Freedom from device-related complications
Measured over 30 days after the index procedure
+1 more outcome measured
Tricuspid Regurgitation
21 sites across 13 states
Germany6
New York2
France2
Italy2
Arizona1
Ohio1
Oregon1
British Columbia1
  • 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

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Eligibility criteria

Inclusion

Patients undergoing Transcatheter Tricuspid Valve Replacement
Native Tricuspid Valve disease
Orthotopic Tricuspid Valve Implantation

Exclusion

Age under 18 years
  • 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