ClinicaliQ Trial Snapshot
- Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation – APOLLO-EU Trial — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT05496998.
- Intervention being tested: Safety and efficacy of Medtronic Intrepid™ Transcatheter Mitral Valve Replacement (TMVR) system as a transfemoral approach in patients with significant mitral valve disease unsuitable for conventional surgery.
- Patient eligibility overview: Adults with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of mitral annular calcification (MAC), who are deemed unsuitable for surgical repair or replacement by the local multidisciplinary team.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.