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NCT06033274Recruiting

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

Montefiore Medical Center

Start Date

10/5/2023

Completion Date

8/1/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Patients undergoing Transcatheter Tricuspid Valve Replacement * Native Tricuspid Valve disease * Orthotopic Tricuspid Valve Implantation Exclusion Criteria: * Age under 18 years

Interventions

DEVICE

Transcatheter Tricuspid Valve Replacement

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Conditions

Tricuspid Regurgitation

Locations

Arizona Heart Hospital (Biltmore Cardiology)

Phoenix, Arizona 85016

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

Montefiore Medical Center

The Bronx, New York 10461

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

St. Paul's Hospital

Vancouver, British Columbia V6Z 1Y6

Canada

St Michael's Hospital, University of Toronto

Toronto, Ontario M5B 1W8

Canada

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

Québec, Quebec G1V 4G5

Canada

Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100

Denmark

Chu De Bordeaux - Haut-Lévêque Hospital

Bordeaux, Pessac 33600

France

Centre Hospitalier Universitaire de Lille

Lille, 59000

France

Clinique Pasteur Toulouse

Toulouse, 31300

France

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

Bad Oeynhausen, 32545

Germany

Heart Center Cologne, University of Cologne

Cologne, 50924

Germany

Cardiovascular Center (CVC) Frankfurt, Division of Cardiology

Frankfurt, 60389

Germany

University Heart and Vascular Center, Department of Cardiology

Hamburg, 20251

Germany

University Heart Center, Schleswig-Holstein University

Lübeck, D-23538

Germany

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

Munich, 80333

Germany

San Raffaele University Hospital

Milan, 20132

Italy

Centro Cardiologico Monzino IRCCS

Milan, 20138

Italy

University Hospital Alvaro Cunqueiro (CHUVI)

Vigo, Pontevedra 36312

Spain