Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
NCT ID: NCT05496998
Last Updated: 2025-12-17
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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RECRUITING
NA
400 participants
INTERVENTIONAL
2023-02-07
2038-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Medtronic Intrepid™ TMVR TF System
Medtronic Intrepid™ TMVR TF System
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery
* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
* Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System
Exclusion Criteria
* Currently surgically implanted mitral valve
* Prior transcatheter mitral valve procedure with device currently implanted
* Anatomic contraindications
* Anatomically prohibitive mitral annular calcification (MAC)
* Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
* LVEF \< 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - \<30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function)
* Left ventricular end diastolic diameter (LVEDD) \> 75mm
* Need for emergent or urgent surgery
* Hemodynamic instability
* History of bleeding diathesis or coagulopathy
* End stage renal disease
* Liver failure
* Frailty
18 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Modine, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
von Bardeleben, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Mainz
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MDT22008TMV005
Identifier Type: -
Identifier Source: org_study_id