NL-OMON42740已完成2 期
MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study - MERIT-FIM
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •* 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.
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