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Transcatheter Mitral Valve Replacement for Severe Mitral Regurgitation

This study is testing a new device called the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement (TMVR) System for people with severe symptomatic mitral regurgitation. Mitral regurgitation is a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward. You might be able to join if you have moderate to severe or severe symptoms and your heart team believes you are not suitable for other mitral valve treatments. The study aims to see how well the device works after one year. The current recruitment status is unclear, but the study plans to enroll 1056 participants.

Study design
This is a global study where all 1056 participants will receive the Medtronic Intrepid™ TMVR System. It is a pre-market trial, meaning it's being done before the device is widely available.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one year to assess the device's effectiveness.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03242642

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

Recruiting
NAAges 18+InterventionalTreatment
Medtronic Cardiovascular
~1,056 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

At a glance

Recruiting sites
73 of 85 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Cohort
Measured over 1 year
+1 more outcome measured

Conditions

Mitral Valve Regurgitation

Explore related trials

Mitral Valve Insufficiency

Where it's being run

85 sites across 33 states
California9
Texas8
New York7
Florida6
Virginia6
Ohio4
Massachusetts3
Michigan3

Study leadership

  • Michael Mack, MD · STUDY_CHAIR · Baylor Scott & White Hospital
  • David Adams, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Martin Leon, MD · PRINCIPAL_INVESTIGATOR · New York Presbyterian Hospital/Columbia University Medical Center

Who to contact

Megan Wilder Fredrickson
[email protected]
612-469-1749
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Primary Cohort1 year

    Composite of all-cause mortality or heart failure hospitalization

  • MAC Cohort1 year

    All-cause mortality