NCT03560167已完成不适用
An Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI 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
- 5
- 试验地点
- 19
- 主要终点
- Safety measured by device-related or procedure-related major adverse events (MAEs)
研究概览
简要总结
This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.
详细描述
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date August 14, 2020.
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 Consortium1; and 2003 ASE Guidelines for grading mitral regurgitation2)
- •Patient has had a prior surgical or percutaneous mitral repair procedure >3 months prior to enrollment
- •LV Ejection Fraction: ≥20 to ≤40%
- •Symptom Status: NYHA II-IV (i.e., ambulatory)
- •Prescribed appropriate guideline-directed medical therapy for heart failure for at least 3 months with stable doses of diuretics, beta-blockers and Angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) for 1 month (with stable defined as no greater than 100% increase of 50% decrease in medication doses). Treatment shall include CRT and/or ICD when indicated by guidelines.
- •Able and willing to complete 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 3 months
- •Prior surgical, transcatheter, or percutaneous mitral valve replacement
- •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)
- •Fixed pulmonary artery systolic pressure >70 mmHg
- •Severe tricuspid regurgitation
- •History of stroke within the prior 3 months or any prior stroke with 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 or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair 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
- •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 CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month
- •Subjects on high dose steroids or immunosuppressant therapy
- •Female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating
研究组 & 干预措施
AccuCinch® Ventricular Restoration System
Experimental
干预措施: AccuCinch® Ventricular Restoration System (Device)
结局指标
主要结局
Safety measured by device-related or procedure-related major adverse events (MAEs)
时间窗: 30-day
Device-related or procedure-related major adverse events (MAEs)
次要结局
未报告次要终点
研究者
研究点 (19)
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