Tendyne European Experience Registry

Recruiting now

Conditions studied: Mitral Regurgitation

In brief

TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.

Key facts

Study ID

NCT04898335

Run by

LMU Klinikum

People needed

400

Starts

2021-04-15

Expected to finish

2027-12-31

Last updated by the study team

2021-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients treated with the Tendyne Mitral Valve System for mitral valve disease in a commercial setting
• Patients providing written informed consent in compliance with the protocol, the ICH-GCP and all national legal and regulatory requirements

You may not qualify if…

• Patients not providing written informed consent

Where it is running

• Royal Brompton London — London, United Kingdom (enrolling)
• Universitaetsklinikum Wien — Vienna, Austria (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• University hospital Oslo — Oslo, Norway (enrolling)
• Puerto de Hierro Madrid — Madrid, Spain (enrolling)
• University hospital Madrid — Madrid, Spain (enrolling)
• Hospital Clinico Valladolid — Valladolid, Spain (enrolling)
• University Hospital of Vigo — Vigo, Spain (enrolling)
• Inselspital Bern — Bern, Switzerland (enrolling)
• Universitaetsklinikum Linz — Linz, Austria (enrolling)
• CHU de Lille — Lille, France (enrolling)
• Clinique Pasteur — Toulouse, France (enrolling)
• Herz- und Diabeteszentrum NRW — Bad Oeynhausen, Germany (enrolling)
• Deutsches Herzzentrum Berlin — Berlin, Germany (enrolling)
• Universitaetsklinikum Bonn — Bonn, Germany (enrolling)
• Universitaetsklinikum Koeln — Cologne, Germany (enrolling)
• Universitätsklinikum Frankfurt — Frankfurt, Germany (enrolling)
• UKE Hamburg — Hamburg, Germany (enrolling)
• Universitätsmedizin Mainz — Mainz, Germany (enrolling)
• DHZ München — Münich, Germany (enrolling)
• Universitaetsklinikum Tuebingen — Tübingen, Germany (enrolling)
• ICH - Istituto Clinico Humanitas — Milan, Italy (enrolling)
• University Hospital of Pisa — Pisa, Italy (enrolling)
• CHU de Bordeaux — Bordeaux, France
• Universitaetsspital Basel — Basel, Switzerland

Full record on ClinicalTrials.gov

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