NL-OMON42740
Completed
Phase 2
MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study - MERIT-FIM
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- heart valve disorder
- Sponsor
- Mitralix Ltd.
- Enrollment
- 4
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has given signed study Informed Consent for participation prior to procedure.
- •\* Subject is \* 18 years of age or legal age in host country
- •\* Subject is willing and able to comply with all required follow\-up evaluations
- •\* Genders eligible for the study: Both genders
- •\* Subject has functional MR of grade 3\+ or more
- •\* Subject has left ventricular ejection fraction (LVEF) \>20 % and \< 40%.
- •\* No contraindications to trans\-septal puncture
- •\* Subject is of functional class 3 or more (NYHA)
- •\- The subject is high risk to undergo MV surgery as assessed and consented by a cardiac surgeon and an intervention cardiologist at the site (center heart team), and according to ESC/EACTS guidelines on the management of valvular heart disease (including minimum STS score\>4%) or subject voluntarily and consciously refuses surgery
- •\* Subject is excluded from other standard of care procedures as determined by center heart team.
Exclusion Criteria
- •\* Mitral Stenosis \* moderate
- •\* Aortic Stenosis/Insufficiency \> moderate
- •\* Subvalvular calcification or calcification of the chordae.
- •\* Subject has a prosthesis valve in the mitral/aortic position
- •\* Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months.
- •\* Subject has a history of a myocardial infarction (MI) in the past 3 months
- •\* Subject refuses blood transfusion or surgical valve replacement.
- •\* Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure \* 7 days of the index procedure
- •\* Subject has a history of, or has active endocarditis
- •\* Subject has echocardiographic evidence of intra\-cardiac mass, thrombus, vegetation or soft\-mobile deposits
Outcomes
Primary Outcomes
Not specified
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