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Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Sponsor: Medtronic Cardiovascular
Summary
Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
Official title: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2023-02-07
Completion Date
2038-12
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
Medtronic Intrepid™ TMVR TF System
Patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC will have a Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR Transfemoral System
Locations (37)
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Clinique Pasteur
Toulouse, Cedex 03, France
CHU Bordeaux
Bordeaux, Pessac Cedex, France
Henri-Mondor University Hospital
Créteil, France
CHU Timone
Marseille, France
CHU de Nantes
Nantes, France
CHU Rennes - Pontchaillou Hospital
Rennes, France
Centre Cardiologique du Nord (CCN)
Saint-Denis, France
CHRU de Tours
Tours, France
Heart and Diabetes Center NRW
Bad Oeynhausen, Germany
Deutsches Herzzentrum der Charité (DHZC)
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Universitäres Herz- und Gefäßzentrum Hamburg
Hamburg, Germany
Herzzentrum Leipzig
Leipzig, Germany
University Medical Center Mainz
Mainz, Germany
Deutsches Herzzentrum München
München, Germany
LMU Clinic of University Hospital München
München, Germany
Universitätsklinikum Ulm
Ulm, Germany
Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi
Bologna, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy
Ospedale San Raffaele
Milan, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Italy
Catharina Hospital
Eindhoven, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Central University Hospital of Asturias
Oviedo, Spain
University Hospital Alvaro Cunqueiro
Vigo, Spain
Universitätsspital Bern
Bern, Switzerland
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London
London, United Kingdom
Royal Brompton Hospital
London, United Kingdom