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NCT06033274 | RECRUITING | Tricuspid Regurgitation


Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
Sponsor:

Montefiore Medical Center

Brief 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.

Condition or disease

Tricuspid Regurgitation

Intervention/treatment

Transcatheter Tricuspid Valve Replacement

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 : OBSERVATIONAL
Estimated Enrollment : 800 participants
Official Title : Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment: the TRIPLACE Registry
Actual Study Start Date : 2023-10-05
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2026-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patients undergoing Transcatheter Tricuspid Valve Replacement
  • * Native Tricuspid Valve disease
  • * Orthotopic Tricuspid Valve Implantation
Exclusion Criteria
  • * Age under 18 years

Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

Location Details

NCT06033274


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Arizona

Arizona Heart Hospital (Biltmore Cardiology)

Phoenix, arizona, United States, 85016

RECRUITING

United States, New York

Columbia University Irving Medical Center

New York, New York, United States, 10032

RECRUITING

United States, New York

Montefiore Medical Center

The Bronx, New York, United States, 10461

RECRUITING

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

ENROLLING BY INVITATION

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

RECRUITING

Canada, British Columbia

St. Paul's Hospital

Vancouver, British Columbia, Canada, V6Z 1Y6

RECRUITING

Canada, Ontario

St Michael's Hospital, University of Toronto

Toronto, Ontario, Canada, M5B 1W8

RECRUITING

Canada, Quebec

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

Québec, Quebec, Canada, G1V 4G5

RECRUITING

Denmark,

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark, 2100

RECRUITING

France, Pessac

Chu De Bordeaux - Haut-Lévêque Hospital

Bordeaux, Pessac, France, 33600

RECRUITING

France,

Lille University Hospital Center

Lille, France, 59000

RECRUITING

France,

Pasteur Clinic Toulouse

Toulouse, France, 31300

RECRUITING

Germany,

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

Bad Oeynhausen, Germany, 32545

RECRUITING

Germany,

Heart Center Cologne, University of Cologne

Cologne, Germany, 50924

RECRUITING

Germany,

Cardiovascular Center (CVC) Frankfurt, Division of Cardiology

Frankfurt, Germany, 60389

RECRUITING

Germany,

University Heart and Vascular Center, Department of Cardiology

Hamburg, Germany, 20251

RECRUITING

Germany,

University Heart Center, Schleswig-Holstein University

Lübeck, Germany, D-23538

RECRUITING

Germany,

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

Munich, Germany, 80333

RECRUITING

Italy,

San Raffaele University Hospital

Milan, Italy, 20132

RECRUITING

Italy,

Monzino IRCCS Cardiology Center

Milan, Italy, 20138

RECRUITING

Spain, Pontevedra

University Hospital Alvaro Cunqueiro (CHUVI)

Vigo, Pontevedra, Spain, 36312

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