Transcatheter Mitral Valve Replacement with the Medtronic Intrepid* TMVR Transfemoral System in patients with severe symptomatic mitral regurgitation - APOLLO-EU Trial

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 24

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).
- 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective;<br /><br>Evaluate one-month efficacy and one-year safety of the Medtronic Intrepid* TMVR<br /><br>TF System<br /><br><br /><br>Primary endpoint:<br /><br>Safety: all-cause mortality at 1-year post-procedure<br /><br>Efficacy: defined as subjects with none/trace or mild regurgitation at 30 days<br /><br>post-procedure as assessed by the Echocardiography Core Laboratory </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objective:<br /><br>Evaluate procedure-related safety and one-year efficacy of the Medtronic<br /><br>Intrepid* TMVR TF System.<br /><br><br /><br>Secondary endpoints:<br /><br>Safety<br /><br>• all-cause mortality at 30 days<br /><br>• Disabling stroke at 30 days<br /><br>• Acute Kidney Injury (stage 3 or with renal replacement) at 30 days<br /><br>• Reoperation or reintervention at 30 days<br /><br>• Major access site vascular complications at 30 days<br /><br><br /><br>Efficacy:<br /><br>• Degree of mitral valve regurgitation at 1 year as assessed by the<br /><br>Echocardiography Core Laboratory<br /><br>• Change in NYHA functional class at 1 year<br /><br>• Change in Quality of Life (QoL) at 1 year as assessed by KCCQ<br /><br>• Cardiovascular hospitalizations through 1 year</p><br>