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NCT05496998Recruiting

Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Official recordSimplified version

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.

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 • Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System

Exclusion criteria

• 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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
No phase (N/A)
Study type
Interventional
Countries
Switzerland, France, Germany, Italy, Denmark, Netherlands, Spain, United Kingdom
Sponsor
Medtronic Cardiovascular(Industry)
Protocol no.
MDT22008TMV005
Conditions
Mitral Regurgitation
Interventions
Device

Treatments studied

  • Medtronic Intrepid™ TMVR TF System

Locations · 37

  • Bern, SwitzerlandUniversitätsspital BernRecruiting at this site
  • Toulouse, FranceClinique PasteurRecruiting at this site
  • Bordeaux, FranceCHU BordeauxRecruiting at this site
  • Créteil, FranceHenri-Mondor University HospitalRecruiting at this site
  • Marseille, FranceCHU TimoneRecruiting at this site
  • Nantes, FranceCHU de NantesRecruiting at this site
  • Rennes, FranceCHU Rennes - Pontchaillou HospitalRecruiting at this site
  • Saint-Denis, FranceCentre Cardiologique du Nord (CCN)Recruiting at this site
  • Tours, FranceCHRU de ToursRecruiting at this site
  • Bad Oeynhausen, GermanyHeart and Diabetes Center NRWRecruiting at this site
  • Berlin, GermanyDeutsches Herzzentrum der Charité (DHZC)Recruiting at this site
  • Bonn, GermanyUniversitätsklinikum BonnRecruiting at this site
  • Hamburg, GermanyUniversitäres Herz- und Gefäßzentrum HamburgRecruiting at this site
  • Leipzig, GermanyHerzzentrum LeipzigRecruiting at this site
  • Mainz, GermanyUniversity Medical Center MainzRecruiting at this site
  • München, GermanyDeutsches Herzzentrum MünchenRecruiting at this site
  • München, GermanyLMU Clinic of University Hospital MünchenRecruiting at this site
  • Ulm, GermanyUniversitätsklinikum UlmRecruiting at this site
  • Bologna, ItalyAzienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola MalpighiRecruiting at this site
  • Brescia, ItalyAzienda Ospedaliera Spedali Civili di BresciaRecruiting at this site
  • Milan, ItalyOspedale San RaffaeleRecruiting at this site
  • Pisa, ItalyAzienda Ospedaliero Universitaria PisanaRecruiting at this site
  • San Donato Milanese, ItalyIRCCS Policlinico San DonatoRecruiting at this site
  • Aarhus, DenmarkAarhus University HospitalRecruiting at this site
  • Copenhagen, DenmarkRigshospitaletRecruiting at this site
  • Odense, DenmarkOdense University HospitalRecruiting at this site
  • Eindhoven, NetherlandsCatharina HospitalRecruiting at this site
  • Nieuwegein, NetherlandsSt. Antonius HospitalRecruiting at this site
  • Rotterdam, NetherlandsErasmus University Medical CenterRecruiting at this site
  • Barcelona, SpainHospital Clínic de BarcelonaRecruiting at this site

In total, worldwide, all 37 sites listed in the registry are recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: July 6, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 7 more locations

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.