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Replacement of the mitral valve using a new device for patients with severe mitral regurgitation

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

Not applicable Interventional Medtronic Cardiovascular · NCT03242642

This study is testing a new device to replace the mitral valve in patients with severe mitral regurgitation who can't use other treatments to see if it is safe and effective.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1056 (estimated)
Ages18 Years and up
SexAll
SponsorMedtronic Cardiovascular Industry-sponsored
Locations85 sites (Birmingham, Alabama and 84 other locations)
Trial IDNCT03242642 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement (TMVR) System in patients suffering from severe symptomatic mitral regurgitation. It is a multi-center, global, prospective, non-randomized interventional trial where all enrolled subjects will receive the study device. The trial aims to assess the safety and effectiveness of this innovative valve replacement approach for patients who are not suitable for existing treatment options.

Who should consider this trial

Good fit: Ideal candidates are individuals with moderate to severe symptomatic mitral regurgitation who are deemed unsuitable for conventional treatments.

Not a fit: Patients with prior transcatheter mitral valve procedures, significant anatomical contraindications, or severe left ventricular dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could provide a less invasive treatment option for patients with severe mitral regurgitation who currently have limited alternatives.

How similar studies have performed: Other studies involving transcatheter valve replacement techniques have shown promising results, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Moderate to severe or severe symptomatic mitral regurgitation
* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention

Exclusion Criteria:

* prior transcatheter mitral valve procedure with device currently implanted
* anatomic contraindications
* prohibitive mitral annular calcification
* left ventricular ejection fraction \<25%
* need for emergent or urgent surgery
* hemodynamic instability

Where this trial is running

Birmingham, Alabama and 84 other locations

+35 more sites — see ClinicalTrials.gov for the full list.

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 Valve RegurgitationHeart diseasevalve diseaseheart valve diseasemitral regurgitationcardiovascular diseasemitral insufficiency
Last reviewed 2026-06-13 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.