MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study

Mitralix

Status

Completed

Conditions

Mitral Valve Regurgitation

Treatments

Device: Mistral implantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT02948231

CL-133

Details and patient eligibility

About

The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Mitral Regurgitation.

The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.

Full description

The study is designed to clinically demonstrate device acute safety (Primary Endpoint) along with longer FU device safety and effectiveness evaluation (Secondary Endpoint).

The main objectives of the study are :

Evaluate the Acute safety of the implanted Mistral device post procedure and at 30 day follow up period.
Evaluate the long term Safety of the device (3 and 6 months follow up).
Demonstrate effectiveness of the Mistral device in improving MR.

Primary endpoints:

• Safety: Acute safety. Rate of device related SAE including device related mortality, stroke, MI, cardiac tamponade, surgery for failed percutaneous repair and non-elective cardiovascular surgery to treat an adverse event. At discharge and 30 days.

Secondary endpoints:

• Safety: Safety at 3 and 6 months. Rate of SAEs and device related SAEs at 3, 6 and 12months.
Effectiveness: MR reduction post-procedure, at discharge and 30 days, 3 and 6 and 12 months. Improved NYHA class and 6MWT distance at 30 days, 3 and 6 and 12 months.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.
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 position
Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration
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.