Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06033274

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Paul's Hospital, Vancouver, British Columbia, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age under 18 years

Treatment and study plan

Transcatheter Tricuspid Valve Replacement

Device

All patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. All-cause mortality

    Time frame: 12 months after the index procedure

    The number of deaths due to any cause will be recorded

  4. 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

  5. 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

  6. Device Thrombosis

    Time frame: 12 months after the index procedure

    The number of participants who have been identified with device thrombosis will be recorded

  7. 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

  8. 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

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Scotti, MD

CONTACT

[email protected]

7189043388

Rishi Puri, MD

CONTACT

[email protected]

(216) 444-2273

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • The Cleveland Clinic
  • University Hospital, Bordeaux
  • University of Toronto

Registry information

Official study title

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

Acronym: TRIPLACE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.