Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
NCT ID: NCT04818502
Last Updated: 2024-06-12
Study Results
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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ACTIVE_NOT_RECRUITING
200 participants
OBSERVATIONAL
2021-05-04
2029-05-31
Brief Summary
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Detailed Description
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The objective of the Tendyne RESOLVE-MR study is to confirm the safety and performance of the Tendyne Mitral Valve System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation (MR) who are considered by the local heart team as eligible for a transapical transcatheter mitral valve implantation in a real-world setting. This clinical study is intended to satisfy post-market clinical follow-up requirements of CE Mark.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits.
3. Patient provides written informed consent prior to any study-specific procedure.
Exclusion Criteria
2. Patient is pregnant or nursing or plan to become pregnant during the study follow-up period.
3. Patient is under the age of 18 or age of legal consent.
4. Patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ABT-CIP-10313
Identifier Type: -
Identifier Source: org_study_id
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