NCT02806570已完成不适用
Early Feasibility Study of the AccuCinch® Ventricular Restoration System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 29
- 主要终点
- 30-Day Safety
研究概览
简要总结
This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy
详细描述
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020
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
- •Study patient is at least 18-years old
- •Severity of FMR: ≥ Moderate (i.e., 2+, according to Stone et al Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles. A Consensus Document from the Mitral Valve Academic Research Consortium11; and 2003 ASE Guidelines for grading mitral regurgitation10)
- •Ejection Fraction: ≥20 to ≤60%
- •Symptom Status: NYHA II-IV (i.e., ambulatory)
- •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 risk score or comorbidities should demonstrate high risk features, as determined by the Heart Team)
- •Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
排除标准
- •Patients with 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 revascularization
- •Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
- •Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures)
- •NYHA class IV (i.e., non-ambulatory) or American College of Cardiology (ACC)/American Heart Association (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.
- •Anatomical pathology/constraints preventing appropriate access/implant of the AccuCinch® Ventricular Restoration System (e.g., femoral arteries will not support a 20F 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
结局指标
主要结局
30-Day Safety
时间窗: 30-day
Assess 30-day safety defined as device-related or procedure-related major adverse events (MAEs). MAE is a composite of death; myocardial infarction; emergent conversion to surgery; stroke; major cardiac structure complication; major vascular complication; and heart failure-related hospitalization.
次要结局
未报告次要终点
研究者
研究点 (29)
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