MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 4

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.
* Patients with femoral veins enabling catheterization with 12Fr catheters
* Life expectancy * 1 year

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
* Subject is in acute pulmonary edema.
* Subject has hemodynamic instability requiring inotropic or mechanical support.
* Subject has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication
* Subject has renal insufficiency as evidenced by a serum Creatinine > 3.0mg/dL.
* Subject has ongoing infection or sepsis
* Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy)
* Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 3 months prior to the index procedure
* Subject requires emergency surgery for any reason
* Subject has a known allergy to Nitinol alloys, 316L\304 stainless steel.
* Pregnant or lactating women.
* Patients being dependent upon the sponsor or upon the investigator or upon the investigational site.
* Subject has a known contrast media allergy
* Presence of high degree atrio-ventricular block (2nd or 3rd degree A-V block), or the presence of tri-fascicular block
* According to investigator on site the patient is suffering from a severe end stage disease (e.g. malignancy, severe pulmonary disease, liver disease, renal failure) and has a life expectancy of less than 1 year.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints:<br /><br>* Primary safety endpoint: Acute Safety. Rate of device related SAE including<br /><br>device related mortality, stroke, MI, cardiac tamponade, surgery for failed<br /><br>percutaneous repair and non-elective cardiovascular surgery to treat an adverse<br /><br>event. At discharge and 30 days.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>* Secondary safety endpoint: Safety at 3 and 6 months. Rate of device related<br /><br>SAE at 3 and 6 months.<br /><br>* Secondary effectiveness endpoint: MR reduction post-procedure, at discharge,<br /><br>30 days, 3 and 6 months.<br /><br>* Improved NYHA class and 6MWT distance at 30 days, 3 and 6 months. </p><br>