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Transcatheter Mitral Valve Replacement for Severe Mitral Regurgitation

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Not applicable Interventional Medtronic Cardiovascular · NCT05496998

This study tests a new heart valve replacement method for people with severe mitral regurgitation who can't have other treatments to see if it helps them feel better.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorMedtronic Cardiovascular Industry-sponsored
Locations37 sites (Aarhus and 36 other locations)
Trial IDNCT05496998 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and efficacy of the Medtronic Intrepid™ transcatheter mitral valve replacement system in patients suffering from severe symptomatic mitral regurgitation. It is a prospective, single-arm, multi-center interventional trial designed for individuals who are deemed unsuitable for existing treatment options. The study aims to provide a new therapeutic approach for patients with specific heart valve conditions, particularly those with moderate-to-severe symptoms or combined mitral stenosis.

Who should consider this trial

Good fit: Ideal candidates are patients with moderate-to-severe symptomatic mitral regurgitation who are not suitable for conventional surgical interventions.

Not a fit: Patients with an estimated life expectancy of less than 24 months or those with a currently implanted mitral valve may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with severe mitral regurgitation who currently have limited options.

How similar studies have performed: Other studies have shown promise with transcatheter approaches for mitral valve issues, indicating a potential for success with this novel intervention.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Aarhus and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mitral RegurgitationmitralvalveregurgitationTMVRIntrepid™symptomaticsevere
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.