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

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Covidien

Status

Enrolling

Conditions

Mitral Valve Regurgitation

Treatments

Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03242642
MDT17022TMV001

Details and patient eligibility

About

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

Enrollment

1,156 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

1,156 participants in 2 patient groups

Primary Cohort- TMVR
Experimental group
Description:
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Treatment:
Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
Mitral Annular Calcification -TMVR
Experimental group
Description:
Treatment of mitral regurgitation with the Medtronic Transcatheter Mitral Valve Replacement System (TMVR)
Treatment:
Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)

Trial contacts and locations

85

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Central trial contact

Megan Wilder Fredrickson

Data sourced from clinicaltrials.gov

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