ACTRN12610000184077招募中不适用
A feasibility study of 30-50 patients to evaluate the clinical response to Patent Foramen Ovale (PFO) closure using Coherex FlatStentTM EF PFO Closure System (EF is part of the trade mark name and stands for Enhanced Foam) in Obstructive Sleep Apnea (OSA) patients with significant right-to-left shunting and oxygen desaturation as demonstrated during sleep studies.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Diagnosis of OSA and a polysomnogram within the past year that demonstrated an apnea index > 20 seconds (AI20) of greater than 5 and an oxygen desaturation index > 6% (ODI6) of greater than 5 associated with apnic events. Patients willing to under go transcranial doppler (TCD) and demonstrates a Grade IV or Grade V right-to-left shunt. Patients must demonstrate a PFO amenable to transcatheter closure with the Coherex FlatStentTM EF PFO Closure System.
排除标准
- •Candidates will be excluded from the study if ANY of the following conditions apply: 1. Long-term requirement for anti-platelet therapy, anticoagulation, or coagulopathy. 2. Contraindication and/or allergy to aspirin, clopidogrel, Nitinol, Dacron, polyurethane, nickel, stainless steel or other stent materials. 3. Concurrent enrollment in another clinical study. 4. Body mass index > 40. 5. Botox treatment within the past 90 days. 6. Other known structural heart disease, coronary artery disease, or atrial fibrillation. 7. Chronic liver disease, kidney disease, or organ failure. 8. Auto-immune disease. 9. Psychiatric illness, which in the investigator’s opinion, will interfere with completion of the study. 10. Degenerative neurologic disorders. 11. Any known active bacterial infection. 12. Malignancy or other illness with a life expectancy less than two years. 13. Pregnancy or desire to become pregnant during course of study. 14. Right-to-left shunt besides PFO detected prior to enrollment. 15.Uncontrolled hypertension defined as blood pressure greater than140/90 mmHg. 16. Immunosuppressive therapy. 17.Diabetes requiring insulin or blood glucose greater than 200 mg/deciliter on oral diabetic medications. 18. Concomitant pulmonary disorder (chronic obstructive pulmonary disorder [COPD], asthma, etc.) requiring treatment. 19. Any medical disorder that would interfere with study completion. 20. Known severe pulmonary hypertension (requiring medication). 21.Patients who have had a major stroke within the past two months or a minor stroke within the past two weeks (see National Institutes of Health (NIH) Stroke Scale). 22. Patients who require a transseptal puncture to access the left atrium. 23. Patients with known sustained arrhythmia.
研究者
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