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ACTIVE NOT RECRUITING
NCT04818502

Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

Summary

To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

Official title: Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation (RESOLVE-MR) (Tendyne™ PMCF Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2021-05-04

Completion Date

2029-05-31

Last Updated

2024-06-12

Healthy Volunteers

Not specified

Interventions

DEVICE

Tendyne™ Mitral Valve System

Transcatheter mitral valve implantation (TMVI) using the Tendyne™ Mitral Valve System , in which a bioprosthetic valve is implanted within the native mitral valve.

Locations (36)

Kepler University Hospital

Linz, Austria

UZ Gasthuisberg

Leuven, Belgium

University Hospital Olomouc

Olomouc, Czechia

IKEM Prague

Prague, Czechia

Hospital AGEL Trinec-Podlesi

Třinec, Czechia

Bordeaux University Hospital

Bordeaux, France

CHRU de Lille

Lille, France

Lyon University Hospital

Lyon, France

Rennes University Hospital

Rennes, France

Clinique Pasteur

Toulouse, France

Heart and Diabetes Center NRW

Bad Oeynhausen, Germany

German Heart Center Berlin

Berlin, Germany

University Hospital Bonn

Bonn, Germany

Universitätsclinic Cologne

Cologne, Germany

University Hospital Frankfurt

Frankfurt, Germany

University Heart Center Hamburg

Hamburg, Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

Leipzig Heart Center

Leipzig, Germany

University Medical Center Mainz

Mainz, Germany

German Heart Center Munich

Munich, Germany

Ludwig-Maximilians-Universität (LMU) München / Campus Großhadern

München, Germany

Robert-Bosch Krankenhaus

Stuttgart, Germany

Shaare Zedek Jerusalem

Jerusalem, Israel

Sheba Medical Centre

Tel Aviv, Israel

Lancisi Cardiovascular Center - Politechnic University of Marcher

Ancona, Italy

AOU Civili Brescia

Brescia, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

MUMC+

Maastricht, Netherlands

Oslo University Hospital

Oslo, Norway

King Fahad Armed Forces

Jeddah, Saudi Arabia

King Fahad Medical City

Riyadh, Saudi Arabia

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

Clinico San Carlos

Madrid, Spain

University Hospital Basel, Clinic for Cardiac Surgery

Basel, Switzerland

Insel Bern

Bern, Switzerland

Royal Brompton Hospital

London, United Kingdom