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Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

NCT ID: NCT06033274

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-05

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tricuspid Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Transcatheter Tricuspid Valve Replacement

Intervention Type DEVICE

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

Interventions

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Transcatheter Tricuspid Valve Replacement

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Age under 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Scotti, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Azeem Latib, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Rishi Puri, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Neil Fam, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michaels Hospital

Thomas Modine, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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Arizona Heart Hospital (Biltmore Cardiology)

Phoenix, Arizona, United States

Site Status RECRUITING

Columbia University Irving Medical Center

New York, New York, United States

Site Status RECRUITING

Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status ENROLLING_BY_INVITATION

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

St Michael's Hospital, University of Toronto

Toronto, Ontario, Canada

Site Status RECRUITING

Quebec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada

Québec, Quebec, Canada

Site Status RECRUITING

Rigshospitalet, Copenhagen University Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Chu De Bordeaux - Haut-Lévêque Hospital

Bordeaux, Pessac, France

Site Status RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, , France

Site Status RECRUITING

Clinique Pasteur Toulouse

Toulouse, , France

Site Status RECRUITING

Heart and Diabetes Centre, North Rhine-Westphalia (NRW), Ruhr-University

Bad Oeynhausen, , Germany

Site Status RECRUITING

Heart Center Cologne, University of Cologne

Cologne, , Germany

Site Status RECRUITING

Cardiovascular Center (CVC) Frankfurt, Division of Cardiology

Frankfurt, , Germany

Site Status RECRUITING

University Heart and Vascular Center, Department of Cardiology

Hamburg, , Germany

Site Status RECRUITING

University Heart Center, Schleswig-Holstein University

Lübeck, , Germany

Site Status RECRUITING

Medical Clinic and Polyclinic, University Hospital of Munich (LMU Klinikum)

Munich, , Germany

Site Status RECRUITING

San Raffaele University Hospital

Milan, , Italy

Site Status RECRUITING

Centro Cardiologico Monzino IRCCS

Milan, , Italy

Site Status RECRUITING

University Hospital Alvaro Cunqueiro (CHUVI)

Vigo, Pontevedra, Spain

Site Status RECRUITING

Countries

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United States Canada Denmark France Germany Italy Spain

Central Contacts

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Andrea Scotti, MD

Role: CONTACT

[email protected]
7189043388

Rishi Puri, MD

Role: CONTACT

[email protected]
(216) 444-2273

Facility Contacts

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Timothy Byrne, DO

Role: primary

[email protected]

Akram W Ibrahim, MD

Role: backup

Rebecca T Hahn, MD

Role: primary

[email protected]

Susheel Kodali, MD

Role: backup

[email protected]

Andrea Scotti, MD

Role: primary

[email protected]
718-904-3388 ext. +1

Azeem Latib, MD

Role: backup

[email protected]
718-904-3388 ext. +1

Rishi Puri, MD

Role: primary

[email protected]
216-444-2273 ext. 1

Samir Kapadia, MD

Role: backup

[email protected]

Robert Boone, MD

Role: primary

[email protected]

Anson Cheung, MD

Role: backup

[email protected]

Neil Fam, MD

Role: primary

[email protected]
(647) 776-2500

Alexandru Patrascu, MD

Role: backup

Josep Rodés-Cabau, MD

Role: primary

[email protected]

Jorge Nuche, MD

Role: backup

Ole De Backer, MD

Role: primary

[email protected]

Davorka Lulic, MD

Role: backup

Thomas Modine, MD

Role: primary

[email protected]
556795679 ext. 33

Augustin Coisne, MD, PhD

Role: primary

[email protected]

Didier Tchétché, MD

Role: primary

[email protected]

Nicolas Dumonteil, MD

Role: backup

[email protected]

Tanja Rudolph, MD

Role: primary

[email protected]

Johannes Kirchner, MD

Role: backup

[email protected]

Matti Adam, MD

Role: primary

[email protected]

Jonathan Curio, MD

Role: backup

[email protected]

Horst Sievert, MD

Role: primary

[email protected]

Kerstin Piayda, MD

Role: backup

[email protected]

Sebastian Ludwig, MD

Role: primary

[email protected]

Niklas Schofer, MD

Role: backup

[email protected]

Christian Frerker, PD Dr.

Role: primary

[email protected]

Jörg Hausleiter, MD

Role: primary

[email protected]

Lukas Stolz, MD

Role: backup

[email protected]

Francesco Maisano, MD

Role: primary

[email protected]

Federica Gramegna, MD

Role: backup

Federico De Marco, MD

Role: primary

[email protected]

Matteo Biroli, MD

Role: backup

[email protected]

Rodrigo Estevez-Loureiro, MD

Role: primary

[email protected]

Julio Echarte-Morales, MD

Role: backup

[email protected]

References

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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 RT, Modine T, Fam N, Latib A. Incidence, Predictors, and Management of Conduction Disturbances After Transcatheter Tricuspid Valve Replacement: The TRIPLACE Registry. JACC Cardiovasc Interv. 2025 Jul 28;18(14):1789-1799. doi: 10.1016/j.jcin.2025.05.029. Epub 2025 Jul 9.

Reference Type RESULT
PMID: 40637674 (View on PubMed)

Other Identifiers

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2023-15312

Identifier Type: -

Identifier Source: org_study_id

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