Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Covidien

Status: Enrolling

Conditions: Mitral Regurgitation

Treatments: Device: Medtronic Intrepid™ TMVR TF System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05496998

MDT22008TMV005

Details and patient eligibility

About

Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.

Full description

Prospective, single-arm, multi-center, interventional, pre-market trial

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC
• Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery
• Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
• Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
• Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System

Exclusion criteria

• Estimated life expectancy of less than 24 months
• Currently surgically implanted mitral valve
• Prior transcatheter mitral valve procedure with device currently implanted
• Anatomic contraindications
• Anatomically prohibitive mitral annular calcification (MAC)
• Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
• LVEF < 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - <30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function)
• Left ventricular end diastolic diameter (LVEDD) > 75mm
• Need for emergent or urgent surgery
• Hemodynamic instability
• History of bleeding diathesis or coagulopathy
• End stage renal disease
• Liver failure
• Frailty

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Medtronic Intrepid™ TMVR TF System

Experimental group

Description:

Medtronic Intrepid™ TMVR TF System

Treatment:

Device: Medtronic Intrepid™ TMVR TF System