Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment (TRIPLACE)

September 3, 2025 updated by: Montefiore Medical Center

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment: the TRIPLACE Registry

The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the timing and onset of conduction disturbances necessitating permanent pacemaker implantation, and how such patients are managed. On this background, the TRIPLACE Registry - an investigator-initiated global multicenter registry - is aimed at better understanding the safety and efficacy of orthotopic TTVR.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary aims of the registry will be:

  • To examine the safety, efficacy, and long-term outcomes of TTVR
  • To assess the incidence of procedural complications and their correlations with adverse clinical outcomes
  • To investigate the impact of different pre/post-procedural factors on peri-procedural complications and long-term outcomes after TTVR
  • To explore the characteristics of patients deemed eligible for TTVR.

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rishi Puri, MD
  • Phone Number: (216) 444-2273
  • Email: purir@ccf.org

Study Locations

  • Canada
    • British Columbia
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St Michael's Hospital, University of Toronto
        • Principal Investigator:
          • Neil Fam, MD
        • Contact:
        • Contact:
          • Alexandru Patrascu, MD
    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
        • Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
        • Principal Investigator:
          • Josep Rodes-Cabau, MD
        • Contact:
        • Contact:
          • Jorge Nuche, MD
  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet, Copenhagen University Hospital
        • Principal Investigator:
          • Ole De Backer, MD
        • Contact:
        • Contact:
          • Davorka Lulic, MD
  • France
      • Lille, France, 59000
        • Recruiting
        • Centre Hospitalier Universitaire De Lille
        • Contact:
        • Principal Investigator:
          • Augustin Coisne, MD
      • Toulouse, France, 31300
    • Pessac
      • Bordeaux, Pessac, France, 33600
        • Recruiting
        • Chu De Bordeaux - Haut-Lévêque Hospital
        • Principal Investigator:
          • Thomas Modine, MD
        • Contact:
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Recruiting
        • Heart and Diabetes Centre, North Rhine-Westphalia (NRW), Ruhr-University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tanja Rudolph
      • Cologne, Germany, 50924
      • Frankfurt, Germany, 60389
      • Hamburg, Germany, 20251
        • Recruiting
        • University Heart and Vascular Center, Department of Cardiology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sebastian Ludwig, MD
      • Lübeck, Germany, D-23538
        • Recruiting
        • University Heart Center, Schleswig-Holstein University
        • Contact:
        • Principal Investigator:
          • Christian Frerker, PD Dr.
      • Munich, Germany, 80333
  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • San Raffaele University Hospital
        • Principal Investigator:
          • Francesco Maisano, MD
        • Contact:
        • Contact:
          • Federica Gramegna, MD
      • Milan, Italy, 20138
  • Spain
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Recruiting
        • University Hospital Alvaro Cunqueiro (CHUVI)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rodrigo Rodrigo Estevez-Loureiro, MD
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Arizona Heart Hospital (Biltmore Cardiology)
        • Principal Investigator:
          • Timothy Byrne, DO
        • Contact:
        • Contact:
          • Akram W Ibrahim, MD
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
        • Principal Investigator:
          • Rebecca Hahn, MD
        • Principal Investigator:
          • Susheel Kodali, MD
        • Contact:
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Azeem Latib, MD
        • Principal Investigator:
          • Andrea Scotti, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Rishi Puri, MD
        • Contact:
          • Rishi Puri, MD
          • Phone Number: 1 216-444-2273
          • Email: purir@ccf.org
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Enrolling by invitation
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing orthotopic Transcatheter Tricuspid Valve Replacement for clinically significant tricuspid valve disease.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Age under 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with Tricuspid Regurgitation undergoing Transcatheter Tricuspid Valve Replacement
Patients having clinically significant tricuspid regurgitation, defined according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease, requiring transcatheter tricuspid valve replacement
Device: Transcatheter Tricuspid Valve Replacement
All patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from device-related complications
Time Frame: 30 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
30 days after the index procedure
Reduction in Tricuspid Regurgitation Severity
Time Frame: 30 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
30 days after the index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Permanent Pacemaker Implantation
Time Frame: 30 days after the index procedure
The number of participants who have received a permanent pacemaker implantation will be recorded
30 days after the index procedure
Combined all-cause mortality or rehospitalization for congestive heart failure
Time Frame: 12 months after the index procedure
The composite of mortality from any cause and participants re-hospitalized for acute decompensated congestive heart failure will be recorded
12 months after the index procedure
All-cause mortality
Time Frame: 12 months after the index procedure
The number of deaths due to any cause will be recorded
12 months after the index procedure
Hospitalization for congestive heart failure
Time Frame: 12 months after the index procedure
The number of participants who have been hospitalized with acute decompensated congestive heart failure will be recorded
12 months after the index procedure
The number of participants with New York Heart Association (NYHA) Stage III or IV heart failure
Time Frame: 12 months after the index procedure

The number of participants who meet either NYHA III or NYHA IV classifications for heart failure will be recorded.

NYHA Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest

NYHA Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients
12 months after the index procedure
Device Thrombosis
Time Frame: 12 months after the index procedure
The number of participants who have been identified with device thrombosis will be recorded
12 months after the index procedure
Tricuspid Regurgitation Severity
Time Frame: 12 months after the index procedure
Tricuspid Regurgitation is measured by transthoracic echocardiography. Assessment of MI severity will be conducted 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. Higher mean scores are indicative of greater TR severity
12 months after the index procedure
Quality of Life - Kansas City Cardiomyopathy Questionnaire
Time Frame: 12 months after the index procedure
Quality of Life is evaluated using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ has a 2-week recall period and includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score that mirrors the key concepts of the NYHA functional class. The symptom, physical limitations, social limitations, and quality of life domains are combined to create an overall summary score, which is the primary health status outcome All scores are represented on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life
12 months after the index procedure
Tricuspid Valve Reintervention
Time Frame: 12 months after the index procedure
The number of participants who undergo tricuspid valve surgical and/or transcatheter reintervention will be summed and recorded
12 months after the index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

The Cleveland Clinic
University of Toronto
University Hospital, Bordeaux

Investigators

  • Principal Investigator: Azeem Latib, MD, Montefiore Medical Center
  • Principal Investigator: Thomas Modine, MD, University Hospital, Bordeaux
  • Principal Investigator: Andrea Scotti, MD, Montefiore Medical Center
  • Principal Investigator: Rishi Puri, MD, The Cleveland Clinic
  • Principal Investigator: Neil Fam, MD, St. Michaels Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 3, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-15312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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