NCT04098328终止不适用
Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation (EXPLORE MR)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 3
- 主要终点
- Primary safety endpoint
研究概览
简要总结
Early feasibility study, single-arm registry design
详细描述
First-In-Human
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years of age or older.
- •Greater than moderate degenerative or functional mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
- •Patient must present with an STS Score less than 10%
- •High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications) as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
- •Mitral valve anatomy deemed unsuitable to be treated with an approved edge-to-edge repair system (e.g., retracted posterior leaflet, lack of leaflet tissue, calcified or cleft posterior leaflet) as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
- •Patient is approved by an independent Patient Eligibility Committee
- •New York Heart Association (NYHA) Functional Class III or IV
- •Patient willing to participate in study and provide signed EC-approved informed consent.
- •Treating physician and patient agree that patient is able to return for all required post- procedure follow-up visits
- •Women of child-bearing potential have a negative pregnancy test
排除标准
- •Severe tricuspid regurgitation
- •Severe aortic stenosis or insufficiency
- •Severe mitral annulus calcification
- •Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
- •Implanted vena cava filter
- •Femoral veins with severe angulation and calcification
- •Contraindication for transesophageal echocardiography (TEE) or MDCT scan.
- •Active infection or endocarditis
- •Previous mitral valve surgery
- •Prior orthotopic heart transplantation
- •Pulmonary artery systolic hypertension > 70mmHg
- •Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus
- •Left ventricular ejection fraction (LVEF) < 30%
- •Implant or revision of any pacing device < 30 days prior to intervention
- •Symptomatic coronary artery disease treated < 30 days prior to study procedure
- •Myocardial infarction requiring intervention < 30 days prior to study procedure
- •Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis
- •Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure
- •Stroke < 180 days prior to study procedure
- •Severe renal insufficiency (creatinine > 3.0 mg/dL) or patient requiring dialysis
- •Cardiogenic shock at time of enrolment
- •Hemodynamic instability requiring inotropic support or mechanical heart assistance
- •Concurrent medical condition with a life expectancy of less than 2 years
- •Pregnancy at time of enrolment
- •History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3,000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL)
- •Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated
- •Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments
- •Emergency situations
- •Company employees or their immediate family members
- •Patient is under guardianship
- •Patient is participating in another clinical study for which follow-up is currently ongoing
结局指标
主要结局
Primary safety endpoint
时间窗: 30 days
All-cause mortality
Improvement from baseline mitral regurgitation
时间窗: 30 days
Grade 2+ or less as evaluated by 2D transthoracic echocardiography
次要结局
- Procedure success according to MVARC2 criteria(30 days)
- Technical success according to MVARC2 criteria(24 hours)
- Device success according to MVARC2 criteria(30 days, 6 and 12 months, and 2 - 5 years post treatment)
- Patient success according to MVARC2 criteria(30 days, 6 and 12 months, and 2 - 5 years post treatment)
- Rate (%) of major adverse events as defined by MVARC2 criteria(Procedure, discharge/7 days, 30 days, 6 and 12 months, and 2 - 5 years post treatment)
研究者
研究点 (3)
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