heart valve disorder mitral valve regurgitation
Conditions
Interventions
Access:
* Trans-septal (TS) access is performed through the femoral vein.
* TS puncture is performed in accordance with IFU.
* Agilis guiding introducer inserted into the left atrium (LA).
* The Mist
Sponsors
Mitralix Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: * Primary safety endpoint: 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
| Measure | Time frame |
|---|---|
| Secondary endpoints: * Secondary safety endpoint: Safety at 3 and 6 months. Rate of device related SAE at 3 and 6 months. * Secondary effectiveness endpoint: MR reduction post-procedure, at discharge, 30 days, 3 and 6 months. * Improved NYHA class and 6MWT distance at 30 days, 3 and 6 months. | — |
Countries
Netherlands
Outcome results
None listed