Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Recruiting now · Not applicable
Conditions studied: Mitral Regurgitation
In brief
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.
Key facts
- Study ID
- NCT05496998
- Run by
- Medtronic Cardiovascular
- People needed
- 400
- Starts
- 2023-02-07
- Expected to finish
- 2038-12-01
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC
- 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
You may not qualify if…
- Estimated life expectancy of less than 24 months
- 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
Where it is running
- Aarhus University Hospital — Aarhus, Denmark (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
- Odense University Hospital — Odense, Denmark (enrolling)
- Clinique Pasteur — Toulouse, Cedex 03, France (enrolling)
- CHU Bordeaux — Bordeaux, Pessac Cedex, France (enrolling)
- Henri-Mondor University Hospital — Créteil, France (enrolling)
- CHU Timone — Marseille, France (enrolling)
- CHU de Nantes — Nantes, France (enrolling)
- CHU Rennes - Pontchaillou Hospital — Rennes, France (enrolling)
- Centre Cardiologique du Nord (CCN) — Saint-Denis, France (enrolling)
- CHRU de Tours — Tours, France (enrolling)
- Heart and Diabetes Center NRW — Bad Oeynhausen, Germany (enrolling)
- Deutsches Herzzentrum der Charité (DHZC) — Berlin, Germany (enrolling)
- Universitätsklinikum Bonn — Bonn, Germany (enrolling)
- Universitäres Herz- und Gefäßzentrum Hamburg — Hamburg, Germany (enrolling)
- Herzzentrum Leipzig — Leipzig, Germany (enrolling)
- University Medical Center Mainz — Mainz, Germany (enrolling)
- Deutsches Herzzentrum München — München, Germany (enrolling)
- LMU Clinic of University Hospital München — München, Germany (enrolling)
- Universitätsklinikum Ulm — Ulm, Germany (enrolling)
- Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi — Bologna, Italy (enrolling)
- Azienda Ospedaliera Spedali Civili di Brescia — Brescia, Italy (enrolling)
- Ospedale San Raffaele — Milan, Italy (enrolling)
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (enrolling)
- IRCCS Policlinico San Donato — San Donato Milanese, Italy (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.