Mi-STITCH™ and Mi-KNOT™ Device Technologies Improvement of Minimally Invasive Mitral Valve Repair - A Single-center, Pilot Clinical Safety & Feasibility Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Primary safety endpoint - 30day Mortality
研究概览
简要总结
The objective of this study is to analyze the safety and efficacy of a novel device for minimally invasive mitral valve repair. Data of the early and intermediate postoperative period will be collected within routine clinical follow-up in order to assess morbidity and mortality as well as echocardiographic parameters.
详细描述
This study is a clinical, single-center pilot-study to evaluate safety and performance of a novel device in minimally invasive mitral valve surgery. Twelve (12) patients with mitral valve regurgitation planned for surgery at Vienna General Hospital (AKH) will be enrolled in the study considering inclusion and exclusion criteria. Mitral valve repair is achieved by replacing the chordae tendinea with expanded polytetrafluoroethylene (ePTFE) sutures either with or without concomitant procedures, such as annuloplasty, resection, or gap closure. These ePTFE sutures are placed between a mitral leaflet and the corresponding papillary muscle using a novel suturing device (Mi-Stitch™). By adjusting the length of the suture, the appropriate coaptation is achieved and prolapse is avoided - resulting in an adequate seal of the valve. The procedure will be assessed according to the primary safety endpoint (30 day mortality) as well as the implantation time. Likewise midterm safety endpoints at 12 months (mortality and observed rate of serious adverse events [SAE]) and procedural times will be analyzed.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe primary mitral valve regurgitation according to current guidelines with indication for mitral valve repair
- •With or without concomitant procedures such as: coronary artery bypass grafting (CABG), other valve repair/replacement, pacemaker implantation, exclusion of left appendage and MAZE (or PVI) procedure, aortic procedures
- •Euroscore II < 8
- •Left ventricle ejection fraction > 35%
- •Life expectancy above 1 year after the intervention based on operator assessment
- •Willing to sign informed consent
- •Willing to undergo all medical follow-ups necessary for the clinical investigations until study termination (echocardiography, blood tests, physical investigation)
排除标准
- •Age <18 years
- •Active endocarditis or myocarditis
- •Previous cardiac surgery
- •Heavily calcified mitral valve annulus
- •Severe mitral stenosis
- •Female pregnant patients
- •Emergency procedures
- •Patient not able to read or understand informed consent
- •Patient not willing to sign informed consent
结局指标
主要结局
Primary safety endpoint - 30day Mortality
时间窗: 30 days
30 day Mortality
Primary efficacy endpoint - Implantation Time
时间窗: intraoperative
Defined as the period from start of valve assessment until the completion of the repair
次要结局
- Secondary safety endpoints - Mortality(1, 6 and 12 months)
- Secondary safety endpoints - Rate of SAEs(1, 6 and 12 months)
- Secondary efficacy endpoints - Procedural times(intraoperative)
研究者
Martin Andreas, M.D.
Assoc. Prof. PD Dr. Martin ANDREAS, MBA, PhD, MEBCTS
Medical University of Vienna