NCT00800046已完成不适用
A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 8
- 主要终点
- Safety through 30 days and reduction in MR acutely and at 30 days.
研究概览
简要总结
Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair.
Purpose: To demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® Ventriculoplasty System to reduce mitral valve regurgitation through subvalvular mitral repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Age ≥ 18 years
- •Severity of FMR: ≥ Moderate (i.e., 2+)
- •Ejection Fraction: ≥ 20% to ≤60%
- •Symptom Status: NYHA II-IVa
- •Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month
- •Surgical risk: Subject is eligible for cardiac surgery (specific EuroSCORE (LES or ESII), STS, or comorbidities should demonstrate high risk features)
- •Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
排除标准
- •Significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets)
- •Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
- •Prior surgical, transcatheter, or percutaneous mitral valve intervention
- •Untreated clinically significant coronary artery disease (CAD) requiring revasularization
- •Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
- •Any planned cardiac surgery within the next 6 months (including right heart procedures)
- •NYHA class (i.e., non-ambulatory) or ACC/AHA Stage D heart failure
- •Fixed pulmonary artery systolic pressure >70 mmHg
- •Severe tricuspid regurgitation (per ASE guidelines and graded by the Echo Core Lab)
- •Modified Rankin Scale ≥ 4 disability
- •Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
- •Mitral valve area less than 4.0 cm2
- •Anatomical pathology/contraints preventing appropriate access/ implant of the AccuCinch System
- •Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2 ; Stage 4 or 5 CKD)
- •Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
- •Active bacterial endocarditis
- •History of stroke within the prior 3 months
- •Subjects in whom anticoagulation or antiplatelet therapy is contraindicated
- •Known allergy to nitinol, polyester, or polyethylene
- •Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure.
- •Life expectancy < 1 year due to non-cardiac conditions
- •Currently participating in another interventional investigational study
- •Implant or revision of any rhythm management device (CRT or CRTD) or implantable cardioverter defibrillator within 1 month
- •Absence of CRT with class I indication criteria for biventricular pacing (left bundle branch block pattern and QRS duration ≥150 ms)
- •On high dose steroids or immunosuppressant therapy
- •Female subjects who are pregnant or lactating
研究组 & 干预措施
AccuCinch® Ventriculoplasty System
Experimental
Patients meeting the enrollment criteria will be treated with the AccuCinch® Ventriculoplasty System.
干预措施: AccuCinch® Ventriculoplasty System (Device)
结局指标
主要结局
Safety through 30 days and reduction in MR acutely and at 30 days.
时间窗: 30 days
次要结局
- Safety and reduction in MR at 1 year.(1 year)
研究者
研究点 (8)
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