Menu
Recruiting NCT06033274

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

— Observational Tricuspid Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter Tricuspid Valve Replacement.
Who it may be relevant to
Registry conditions: Tricuspid Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, Denmark, France, Germany +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Freedom from device-related complications [Time frame: 30 days after the index procedure]
  • Reduction in Tricuspid Regurgitation Severity [Time frame: 30 days after the index procedure]
Secondary outcome measures (9)
  • Permanent Pacemaker Implantation [Time frame: 30 days after the index procedure]
  • Combined all-cause mortality or rehospitalization for congestive heart failure [Time frame: 12 months after the index procedure]
  • All-cause mortality [Time frame: 12 months after the index procedure]
  • Hospitalization for congestive heart failure [Time frame: 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]
  • Device Thrombosis [Time frame: 12 months after the index procedure]
  • Tricuspid Regurgitation Severity [Time frame: 12 months after the index procedure]
  • Quality of Life - Kansas City Cardiomyopathy Questionnaire [Time frame: 12 months after the index procedure]
  • Tricuspid Valve Reintervention [Time frame: 12 months after the index procedure]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Age under 18 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 6 centers
  • Heart and Diabetes Centre, North Rhine-Westphalia (NRW), Ruhr-University — Bad Oeynhausen
  • Heart Center Cologne, University of Cologne — Cologne
  • Cardiovascular Center (CVC) Frankfurt, Division of Cardiology — Frankfurt
  • University Heart and Vascular Center, Department of Cardiology — Hamburg
  • University Heart Center, Schleswig-Holstein University — Lübeck
  • Medical Clinic and Polyclinic, University Hospital of Munich (LMU Klinikum) — Munich
United States · 5 centers
  • Arizona Heart Hospital (Biltmore Cardiology) — Phoenix
  • Columbia University Irving Medical Center — New York
  • Montefiore Medical Center — The Bronx
  • Cleveland Clinic — Cleveland
  • Oregon Health & Science University — Portland
Canada · 3 centers
  • St. Paul's Hospital — Vancouver
  • St Michael's Hospital, University of Toronto — Toronto
  • Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada — Québec
France · 3 centers
  • Chu De Bordeaux - Haut-Lévêque Hospital — Bordeaux
  • Centre Hospitalier Universitaire de Lille — Lille
  • Clinique Pasteur Toulouse — Toulouse
Italy · 2 centers
  • San Raffaele University Hospital — Milan
  • Centro Cardiologico Monzino IRCCS — Milan
Denmark · 1 center
  • Rigshospitalet, Copenhagen University Hospital — Copenhagen
Spain · 1 center
  • University Hospital Alvaro Cunqueiro (CHUVI) — Vigo

Publications

  • Scotti A, Puri R, Sturla M, Zahr F, Boone R, Kodali S, Tchetche D, De Backer O, Coisne A, Ludwig S, Stolz L, Estevez Loureiro R, Adam M, De Marco F, Ho EC, Cheung A, Moey M, Ong G, Chadderdon S, Lulic D, Bartkowiak J, Echarte J, Sievert H, Byrne T, Maisano F, Frerker C, Dumonteil N, Oliva OA, Rudolph TK, Kirchner J, Bakhtadze B, Kapadia SR, Rodes-Cabau J, Schofer N, Granada J, Hausleiter J, Hahn R PMID 40637674
  • Scotti A, Latib A, Filtz A, Sturla M, Zahr F, Boone R, Kodali S, Tchetche D, De Backer O, Coisne A, Ludwig S, Garcia SA, Stolz L, Loureiro RE, Adam M, De Marco F, Ho EC, Cheung A, Biroli M, Patrascu A, Alnasser S, Chadderdon S, Lulic D, Bartkowiak J, Echarte-Morales J, Sievert H, Byrne T, Maisano F, Frerker C, Dumonteil N, Oliva OA, Rudolph TK, Rudolph F, Guddeti R, Bakhtadze B, Krishnaswamy A, Ka PMID 41881643
  • Traynor BP, Scotti A, Puri R, Sturla M, Zahr F, Boone R, Kodali S, Tchetche D, De Backer O, Coisne A, Ludwig S, Stolz L, Loureiro RE, Adam M, De Marco F, Biroli M, Ho EC, Cheung A, Patrascu A, Alnasser S, Chadderdon S, Lulic D, Bartkowiak J, Echarte-Morales J, Sievert H, Byrne T, Maisano F, Frerker C, Dumonteil N, Oliva OA, Rudolph TK, Rudolph F, Krishnaswamy A, Kapadia SR, Portillo JD, Rodes-Caba PMID 41575411

Identifiers

NCT: NCT06033274 · 2023-15312

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗