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||Phase|
|Atrial Fibrillation||Procedure: Remote ischemic preconditioning (RIPC) Procedure: sham-intervention||Not Applicable|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|