NCT02948231已完成不适用
MERIT Study - Mistral Percutaneous Mitral Valve Repair FIM Study
Mitralix2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2016年6月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
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 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.
结局指标
主要结局
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.
时间窗: at 30 days post-procedure
次要结局
- Safety: Rate of device related SAE(at 12 months post procedure)
- Effectiveness: MR Grade reduction.(at 12 months post procedure)
- Effectiveness: NYHA class (categorization of heart failure extent).(Post procedure (1 hour after implant device has been implanted))
- Effectiveness: NYHA class (categorization of heart failure extent)(at 12 months post procedure)
- Effectiveness: 6MWT distance.(at 12 months post procedure)
研究者
研究点 (2)
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