Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgit
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 experi
| Condition(s) | Mitral Regurgitation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * 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 * |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Medtronic Cardiovascular |
| Locations | Aarhus, Denmark; Copenhagen, Denmark; Odense, Denmark; Toulouse, Cedex 03, France; Bordeaux, Pessac Cedex, France; Créteil, France (+31 more sites) |
| Start date | 2023-02-07 |
| NCT ID | NCT05496998 |
| Official listing | https://clinicaltrials.gov/study/NCT05496998 |