Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- sustainability of Atrial Fibrillation measured in seconds
研究概览
简要总结
The aim of the study is to examine the effect of RIPC on physiological parameters in non-valvular paroxysmal atrial fibrillation. Furthermore the study will provide a unique bio-date base for further analysis of molecular and genetic mechanisms responsible for observed results.
The potential effect of RIPC on AF inducibility and/or prothrombotic activity might be implemented as additional treatment component to reduce AF burden and minimize thromboembolic risk.
Interim Analysis will be done after 73 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •planned invasive Atrial Fibrillation ablation
排除标准
- •AF in ECG at Admission
- •history of AF ablation
- •pregnancy
- •neoplastic disorders
- •acute or systemic inflammation, autoimmune diseases
- •documented atrial flutter
研究组 & 干预措施
RIPC-Group
After randomization patients will undergo 3 sessions of RIPC (Remote ischemic preconditioning) intervention: I) on preoperative day, II) 1 h before and III) directly before the blood sample collection and invasive measurement of electrophysiological parameters.
干预措施: Remote ischemic preconditioning (RIPC) (Procedure)
Control-Group
After randomization patients will undergo 3 sessions of sham-intervention: I) on preoperative day, II) 1 h before and III) directly before the blood sample collection and invasive measurement of electrophysiological parameters.
干预措施: sham-intervention (Procedure)
结局指标
主要结局
sustainability of Atrial Fibrillation measured in seconds
时间窗: during the Atrial Fibrillation Ablation procedure
inducibility of Atrial Fibrillation by high-rate pacing of 20 s
时间窗: during the Atrial Fibrillation Ablation procedure
次要结局
未报告次要终点
研究者
Jedrzej Kosiuk
MD Jedrzej Kosiuk
Heart Center Leipzig - University Hospital