NL-OMON56063
Recruiting
Not Applicable
Transcatheter Mitral Valve Replacement with the Medtronic Intrepid* TMVR Transfemoral System in patients with severe symptomatic mitral regurgitation - APOLLO-EU Trial - APOLLO-EU trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- leaking heart valve
- Sponsor
- Medtronic B.V.
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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
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
Outcomes
Primary Outcomes
Not specified
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