Global registry of transcatheter tricuspid valve replacement
Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment: the TRIPLACE Registry
This registry will collect information to see how transcatheter tricuspid valve replacement performs and what complications happen in adults with native tricuspid regurgitation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 21 sites (Phoenix, Arizona and 20 other locations) |
| Trial ID | NCT06033274 on ClinicalTrials.gov |
What this trial studies
The TRIPLACE Registry is a global, multicenter observational program collecting clinical and procedural data on adults undergoing orthotopic transcatheter tricuspid valve replacement (TTVR). Participating centers will record procedural details, in-hospital events, conduction disturbances including timing of permanent pacemaker implantation, and long-term clinical outcomes. Analyses will explore how pre- and post-procedural factors relate to peri-procedural complications and subsequent adverse events. Enrollment is limited to patients treated as part of routine care at participating sites.
Who should consider this trial
Good fit: Adults (age 18 and older) with native tricuspid valve disease who undergo orthotopic transcatheter tricuspid valve replacement at a participating center.
Not a fit: Patients under 18, those not receiving TTVR, or patients with prior prosthetic tricuspid valves are not eligible and are unlikely to obtain direct benefit from this registry's findings.
Why it matters
Potential benefit: If successful, the registry could clarify which patients benefit most from TTVR and help reduce procedural complications through better patient selection and management.
How similar studies have performed: Early device-specific and single-center series have shown promising procedural feasibility and short-term results, but robust multicenter long-term evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing Transcatheter Tricuspid Valve Replacement * Native Tricuspid Valve disease * Orthotopic Tricuspid Valve Implantation Exclusion Criteria: * Age under 18 years
Where this trial is running
Phoenix, Arizona and 20 other locations
- Arizona Heart Hospital (Biltmore Cardiology) — Phoenix, Arizona, United States (Recruiting)
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Enrolling_by_invitation)
- St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
- St Michael's Hospital, University of Toronto — Toronto, Ontario, Canada (Recruiting)
- Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada — Québec, Quebec, Canada (Recruiting)
- Rigshospitalet, Copenhagen University Hospital — Copenhagen, Denmark (Recruiting)
- Chu De Bordeaux - Haut-Lévêque Hospital — Bordeaux, Pessac, France (Recruiting)
- Centre Hospitalier Universitaire de Lille — Lille, France (Recruiting)
- Clinique Pasteur Toulouse — Toulouse, France (Recruiting)
- Heart and Diabetes Centre, North Rhine-Westphalia (NRW), Ruhr-University — Bad Oeynhausen, Germany (Recruiting)
- Heart Center Cologne, University of Cologne — Cologne, Germany (Recruiting)
- Cardiovascular Center (CVC) Frankfurt, Division of Cardiology — Frankfurt, Germany (Recruiting)
- University Heart and Vascular Center, Department of Cardiology — Hamburg, Germany (Recruiting)
- University Heart Center, Schleswig-Holstein University — Lübeck, Germany (Recruiting)
- Medical Clinic and Polyclinic, University Hospital of Munich (LMU Klinikum) — Munich, Germany (Recruiting)
- San Raffaele University Hospital — Milan, Italy (Recruiting)
- Centro Cardiologico Monzino IRCCS — Milan, Italy (Recruiting)
- University Hospital Alvaro Cunqueiro (CHUVI) — Vigo, Pontevedra, Spain (Recruiting)
Study contacts
- Principal investigator: Andrea Scotti, MD — Montefiore Medical Center
- Study coordinator: Andrea Scotti, MD
- Email: ascotti@montefiore.org
- Phone: 7189043388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.