NCT01385670Unknown不适用
InterSEPT: In-Tunnel SeptRx European PFO Trial: A Prospective, Multi-Center Study to Evaluate the Safety and Performance of the SeptRx IPO PFO Closure System
SeptRx, Inc.2 个研究点 分布在 2 个国家目标入组 70 人开始时间: 2011年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Safety: Major Adverse Events defined as composite rate of all death, stroke, device embolization, tamponade, and device related re-intervention or surgery
研究概览
简要总结
The objective of this study is to determine the safety, performance, and effectiveness of the SeptRx IPO PFO Closure System in the treatment of Patent Foramen Ovale (PFO) in patients who are amenable to percutaneous closure of their PFO defects.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be ≥ 18 years of age and ≤ 70 years of age
- •The patient is willing to comply with specified follow-up evaluations
- •The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written Notice of Informed Consent, approved by the appropriate Ethics Committee (EC)
- •PFO flat width of 4-14mm (approximate PFO balloon diameter of 2.5-9mm) and PFO length of 4-20mm
排除标准
- •Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure
- •Other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.)
- •Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, Nitinol, and/or contrast sensitivity that cannot be adequately pre-medicated
- •Currently participating in another investigational study, or participation in another clinical trial in the previous 3 months
- •PFO flat width <4mm or >14mm to begin the trial. PFO flat width <4mm or >19mm when the second size device is ready
- •PFO length <4mm or >20mm
- •Active endocarditis, active bacterial infection, or other infection producing bacteremia or sepsis
- •History of chronic or sustained arrhythmia
- •Congenital or structural heart disease other than PFO
- •Thrombus at the intended site of implant or documented venous thrombosis in venous access
- •Severe pulmonary hypertension
- •Vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction
- •Acute appendicitis
- •Confinement to bed (increased risk for clot formation)
- •Prior cardiac surgery, including implantation of active cardiac devices
结局指标
主要结局
Safety: Major Adverse Events defined as composite rate of all death, stroke, device embolization, tamponade, and device related re-intervention or surgery
时间窗: One (1) month
次要结局
- Efficacy: Device success defined as PFO closure at 6 months post procedure by transesophageal echocardiography (TEE) with contrast valsalva bubble study.(Six (6) months)
研究者
研究点 (2)
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