Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study (RIPPAF)
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|ClinicalTrials.gov Identifier: NCT02779660|
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : August 22, 2017
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.
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Procedure: Remote ischemic preconditioning (RIPC) Procedure: sham-intervention|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||September 2018|
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.
Procedure: Remote ischemic preconditioning (RIPC)
RIPC will be induced by the application of 3 short episodes (5 minutes) of forearm ischemia by cuff sphygmomanometer inflation separated by 5 minutes of reperfusion.
Placebo Comparator: 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.
In the control group the cuff will be inflated for 3 times at 10 mm Hg for 5 minutes with 5-minute intervals
- inducibility of Atrial Fibrillation by high-rate pacing of 20 s [ Time Frame: during the Atrial Fibrillation Ablation procedure ]
- sustainability of Atrial Fibrillation measured in seconds [ Time Frame: during the Atrial Fibrillation Ablation procedure ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779660
|Contact: Jedrzej Kosiuk, MD||Jedrzej.Kosiuk@helios-kliniken.de|
|Leipzig, Germany, 04289|
|Contact: Jedrzej Kosiuk Jedrzej.Kosiuk@helios-kliniken.de|