VIenna Pilot Study for Automated Annular Suturing Technology to Assist in Aortic & Mitral Valve Replacement - A Single-center Clinical Safety & Feasibility Pilot Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Freedom from mortality at 30 days post-OP assessed by clinical follow-up reports.
研究概览
简要总结
The objective of this study is to compare surgical outcomes between patients who underwent valve replacement with and without the help of the automated annular suturing technology. In addition, 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. 30 Patients (n=20 aortic valve replacement/ n=10 mitral valve replacement) with aortic and mitral valve pathology, highly likely for prosthetic valve replacement, who are planned for surgery at the Vienna General Hospital (AKH) will be included in this study with respect to the inclusion and exclusion criteria. The patients will undergo aortic or prosthetic mitral valve replacement using a specified automated annular suturing system for placement of the annular pledgeted sutures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients with low to moderate operative risk (Defined by STS mortality risk below 8%)
- •Patients above the age of 18 years
- •Patients willing and able to sign the informed consent
排除标准
- •Patients with active endocarditis
- •Patients with previous cardiac surgery other than pacemaker implantation
- •Emergency procedures
- •Patient who did not sign the informed consent form and/ or refuse to participate
- •Patients unable to read or understand the informed consent
结局指标
主要结局
Freedom from mortality at 30 days post-OP assessed by clinical follow-up reports.
时间窗: 30 days post surgical valve replacement
Follow-ups 30 days post-OP are performed and freedom from mortality evaluated.
Implantation time assessed by surgical report.
时间窗: procedural
Implantation time, the duration defined from start of the valve assessment until the completion of the prosthesis implantation (defined as fixation of the last suture) assessed by surgical report.
次要结局
- Surgical times assessed by surgical report.(procedural)
- Freedom from severe adverse events at 30 days post-OP assessed by clinical follow-up reports(30 days post surgical valve replacement)
研究者
Martin Andreas, M.D.
Assoc. Prof. PD MD MBA, PhD, MEBCTS
Medical University of Vienna