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

ConditionMitral Valve Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronic Cardiovascular

About this trial

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

prior transcatheter mitral valve procedure with device currently implanted

anatomic contraindications

prohibitive mitral annular calcification

left ventricular ejection fraction <25%

Trial design

Design model

Single group

Treatments tested in this trial

  • Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

    Device

    mitral valve replacement

  • Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

    Device

    Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR) mitral valve replacement

Treatment groups

1,056 Participants
are divided into 2 treatment groups
Group A: Primary Cohort- TMVRExperimental treatment 1 intervention
Group B: Mitral Annular Calcification -TMVRExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Cohort

Composite of all-cause mortality or heart failure hospitalization

Time frame
1 year
2

MAC Cohort

All-cause mortality

Time frame
1 year

Secondary outcomes

1

All-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding

Composite

Time frame
30 days or hospital discharge (whichever is later)
2

Degree of mitral regurgitation

measured by echocardiography

Time frame
6 months
3

Quality of Life Improvement

measured by KCCQ

Time frame
3 months (KCCQ)
4

Change in New York Heart Association Class

change in NYHA Class

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medtronic Cardiovascular

Lead sponsor

Source ClinicalTrials.gov
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