Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
Launched by MONTEFIORE MEDICAL CENTER · Sep 5, 2023
Trial Information
Current as of November 11, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
The TRIPLACE Registry is an international, real-world study that collects information about people who have a transcatheter tricuspid valve replacement (TTVR) for significant disease of the tricuspid valve (the valve on the right side of the heart). It is an observational, non-randomized registry, meaning doctors simply record outcomes from standard care rather than testing a new treatment against another. The goal is to understand how safe and effective TTVR is in everyday practice, including any complications around the procedure and how patients do over about a year. The study plans to enroll around 200 participants and is led by Montefiore Medical Center with other centers around the world; results have not been reported yet.
Eligibility is for adults 18 and older of any sex who are undergoing native (non-replaced) tricuspid valve disease and are receiving a transcatheter tricuspid valve replacement. The study is enrolling by invitation at centers including Montefiore (Bronx, NY), Cleveland Clinic (Ohio), St. Thomas Elgin General Hospital (Ontario, Canada), and Chu De Bordeaux (France). Participants can expect to have the valve replacement through a catheter and then be followed with routine check-ups for up to 12 months. Outcomes tracked include whether a permanent pacemaker is needed within 30 days, death or heart-failure hospitalizations within 12 months, changes in the severity of tricuspid regurgitation, quality of life (measured by the KCCQ), and whether any reinterventions on the tricuspid valve are required, among other measures. This study does not alter standard care and does not involve sharing individual patient data publicly.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients undergoing Transcatheter Tricuspid Valve Replacement
- • Native Tricuspid Valve disease
- • Orthotopic Tricuspid Valve Implantation
- Exclusion Criteria:
- • Age under 18 years
About Montefiore Medical Center
Montefiore Medical Center is a leading academic medical institution located in the Bronx, New York, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a principal sponsor of clinical studies, Montefiore fosters a collaborative environment that connects researchers, healthcare professionals, and patients to explore cutting-edge therapies and improve health outcomes. With a strong emphasis on patient-centered care, the center integrates its extensive clinical expertise with robust research capabilities to address a wide range of medical conditions, contributing significantly to the advancement of medical science and clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bronx, New York, United States
Cleveland, Ohio, United States
Bronx, New York, United States
Saint Thomas, Ontario, Canada
Bordeaux, Pessac, France
Patients applied
Trial Officials
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported