Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Closure Rates of PFO and ASD
研究概览
简要总结
The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of Atrial Septal Aneurysm (ASA) and rate of recurrent neurologic embolic events in patients with cryptogenic stroke and PFO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASD (less than 1 cm with redundant septal tissue)
- •Trans Septal Puncture Sites
- •ASA (when an appropriate PFO or small ASD defect is present)
- •Trans ischemic Attack (TIA)
- •Platypnea Orthodeoxia Syndrome
- •Decompression Illness
排除标准
- •Patients under 18 and over 65
- •Patients who are not fluent in English
研究组 & 干预措施
PFO Closure Rate
Evaluate closure rate of clinically relevant septal defects including PFO, ASD (less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of ASA (when an appropriate PFO or small ASD defect is present) and rate of recurrent neurologic embolic event in patients with cryptogenic stroke and PFO
干预措施: Published PFO Device Closure (Device)
Published PFO Device Closure
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials.
干预措施: PFO Closure Rate (Device)
PFO Closure Rate
Evaluate closure rate of clinically relevant septal defects including PFO, ASD (less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of ASA (when an appropriate PFO or small ASD defect is present) and rate of recurrent neurologic embolic event in patients with cryptogenic stroke and PFO
干预措施: PFO Closure Rate (Device)
Published PFO Device Closure
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials.
干预措施: Published PFO Device Closure (Device)
结局指标
主要结局
Closure Rates of PFO and ASD
时间窗: 12 months
Saline Contrast Echo
次要结局
- Recurrent Stroke Rate(4-6 weeks, 6 months, 1 year and annually up to five years)
研究者
James Thompson, MD
Interventional Cardiologist
HeartStitch.Com