Electrophysiological and Echocardiographic PREDICTors of Atrial Fibrillation Following Interventional Closure of Patent Foramen Ovale in Cryptogenic Stroke: PREDICT-AF-PFO
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in baseline heart rhythm, e.g. new-onset atrial fibrillation
研究概览
简要总结
Interventional closure of patent foramen ovale (PFO) associates with reduced risk of stroke recurrence in patients with cryptogenic ischemic stroke as reported in the recent CLOSE and REDUCE trials. The long-term follow-up results of the RESPECT and DEFENSE-PFO trial confirmed these findings. PFO closure is therefore recommended in patient with cryptogenic ischemic stroke and PFO according to the current German interdisciplinary guidelines. It is likely that the number of PFO closure procedures will increase significantly in the near future. However, new onset atrial fibrillation (AF) appears to increase in patients following this procedure. In the REDUCE study, new onset atrial fibrillation was detected in 6.6% patients in the PFO closure group compared with 0.4% in the control group (medical treatment); 59% of these patients were diagnosed within the first two weeks following the procedure and 83% within 45 days, respectively. These results were consistent with the CLOSE study: AF was detected in 4.6% patients in the intervention group vs. 0.9% in the control group. Up until today, markers to identify and quantify the individual risk of AF onset are lacking. Furthermore, under-reporting and under-detection of AF occurrence after PFO closure is likely. This study is designed to to assess the prevalence and and identification of electrophysiological and echocardiographic parameters of new-onset AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous embolic stroke with undetermined source with…
- •palpitations with clinical indication for an electrophysiological study (control group)
- •PFO and clinical indication for interventional PFO closure according to current guidelines (intervention group)
- •Sinus rhythm at time of inclusion with no history of AF
- •Planned EP study due to reported palpitations or documented burden of non-sustained atrial arrythymias (>100 atrial ectopic beats /24 hours, atrial tachycardia)
- •Written informed consent
排除标准
- •previously documented AF
- •indication for therapeutic anticoagulation
- •uncontrolled diabetes mellitus
- •acute coronary syndrom or acute cardiac decompensation within the last 6 months before enrollment
- •enrolled in another study
- •BMI > 40 kg/m²
- •patients who are pregnant of breastfeeding life expectancy < 6 months
- •relevant peripheral artery disease
- •substance abuse
结局指标
主要结局
Change in baseline heart rhythm, e.g. new-onset atrial fibrillation
时间窗: 1, 3, 6, 12 months
Rate of detection of new-onset atrial fibrillation with Holter and loop recorder monitoring after electrophysiological study
次要结局
- Relevance of atrial refractory periods and inducibility of atrial arrhythmias during the electrophysiological study(12 months)
- Change in left atrial morphology (LA volume index) following PFO closure(12 months)
- Change in left atrial function (LA strain) following PFO closure(12 months)
- Change in new-onset AF following PFO closure(12 months)
研究者
Christian Ukena
Head of cardiac electrophysiology department
University Hospital, Saarland