Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR Transfemoral System in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Medtronic Cardiovascular37 sites in 8 countries400 target enrollmentFebruary 7, 2023

ConditionsMitral Regurgitation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mitral Regurgitation
Sponsor: Medtronic Cardiovascular
Enrollment: 400
Locations: 37
Primary Endpoint: Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

February 7, 2023

End Date

December 1, 2038

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Cardiovascular

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.

Time Frame: 30 days

Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure as assessed by the Echocardiography Core Laboratory.

Safety: all-cause mortality at 1-year post-procedure.

Time Frame: 1 year

Rate of all-cause mortality at 1-year post-procedure.

Secondary Outcomes

Quality of Life (QoL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) (Efficacy).(1 year)
Rate of all-cause mortality (Safety).(30 days)
Disabling stroke (Safety).(30 days)
Acute Kidney Injury (stage 3 or with renal replacement) (Safety).(30 days)
Major access site vascular complications (Safety).(30 days)
NYHA functional class (Efficacy).(1 year)
Reoperation or reintervention (Safety).(30 days)
Mitral valve regurgitation (Efficacy).(1 year)
Cardiovascular hospitalizations (Efficacy).(1 year)