Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Remote Ischemic Preconditioning on Electrophysiological and Biomolecular Parameters in Non-valvular Paroxysmal Atrial Fibrillation: RIPPAF Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Remote ischemic preconditioning (RIPC)
* Procedure: sham-intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: planned invasive Atrial Fibrillation ablation Exclusion Criteria: AF in ECG at Admission history of AF ablation age <18 pregnancy neoplastic disorders acute or systemic inflammation, autoimmune diseases documented atrial flutter

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPC-Group<br>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)<br>* 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.<br>|
| Placebo Comparator: Control-Group<br>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. | Procedure: sham-intervention<br>* In the control group the cuff will be inflated for 3 times at 10 mm Hg for 5 minutes with 5-minute intervals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inducibility of Atrial Fibrillation by high-rate pacing of 20 s |  | during the Atrial Fibrillation Ablation procedure | 
| sustainability of Atrial Fibrillation measured in seconds |  | during the Atrial Fibrillation Ablation procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation