Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment (TRIPLACE)

September 11, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
      • Montreal, Quebec, Canada, H1T 1C8
        • Recruiting
        • Montréal Heart Institute (MHI)
        • Principal Investigator:
          • Walid Ben Ali, MD
        • Contact:
        • Contact:
          • Sebastián Mrad, MD
      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
        • Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada
        • Principal Investigator:
          • Josep Rodés-Cabau, MD
        • Contact:
        • Contact:
          • Juan del Portillo, MD
  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Recruiting
        • Rigshospitalet, Copenhagen University Hospital
        • Principal Investigator:
          • Ole De Backer, MD
        • Contact:
        • Contact:
          • Yusuke Kobari, MD
  • France
    • Haute-Garonne
    • Hauts-de-France
      • Lille, Hauts-de-France, France, 59000
      • Lille, Hauts-de-France, France, 59000
        • Recruiting
        • Hospital Center University De Lille (CHU Lille)
        • Contact:
          • Augustin Coisne, MD
        • Principal Investigator:
          • Augustin Coisne, MD
        • Contact:
          • Arnaude Sudre, MD
    • 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
      • Hamburg, Germany, 20251
        • Recruiting
        • University Heart and Vascular Center, Department of Cardiology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sebastian Ludwig, MD
    • Bavaria
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60389
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Recruiting
        • University of Duisberg-Essen, West German Heart and Vascular Centre
        • Contact:
        • Principal Investigator:
          • Amir Abbas Mahabadi, MD
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, D-23538
  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • San Raffaele University Hospital
        • Principal Investigator:
          • Francesco Maisano, MD
        • Contact:
        • Contact:
          • Federica Gramegna, MD
      • Milan, Lombardy, Italy, 20138
  • Spain
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clínico Universitario de Valladolid
        • Principal Investigator:
          • Ignacio J Amat Santos, MD
        • Contact:
        • Contact:
          • Mario Garcia Gomez, MD
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Recruiting
        • University Hospital Alvaro Cunqueiro (CHUVI)
        • Principal Investigator:
          • Rodrigo Estevez-Loureiro, MD
        • Contact:
        • Contact:
  • Switzerland
      • Zurich, Switzerland, CH-8008
        • Recruiting
        • HerzZentrum Hirslanden Zürich
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4031
        • Recruiting
        • University Hospital Basel
        • Contact:
          • Mohammad Kassar, MD
        • Principal Investigator:
          • Mohammad Kassar, 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
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Ascension Via Christi
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
          • Ryan K Kaple, MD
        • Contact:
        • Principal Investigator:
          • Ryan K Kaple, MD
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
        • Principal Investigator:
          • Susheel Kodali, MD
        • Contact:
        • Principal Investigator:
          • Rebecca T Hahn, MD
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Azeem Latib, MD
        • Principal Investigator:
          • Andrea Scotti, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital
        • Principal Investigator:
          • Santiago Garcia, MD
        • Contact:
          • Santiago Garcia, MD
        • Contact:
          • Raviteja Guddeti, MD
      • 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, 97225
        • Recruiting
        • Providence St. Vincent Medical Center
        • Contact:
        • Principal Investigator:
          • Brandon M Jones, MD
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Montefiore Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Cleveland Clinic
University of Toronto
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-15312
  • 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)

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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