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

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: 1,056 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)

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1,056 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)

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)

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