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

Not Applicable

• Conditions: Atrial Fibrillation
• Interventions: Procedure: sham-intervention; Procedure: Remote ischemic preconditioning (RIPC)

• Registration Number: NCT02779660
• Lead Sponsor: Jedrzej Kosiuk

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-20
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22
• Primary Completion: 2018-05
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control-Group	sham-intervention	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.
RIPC-Group	Remote ischemic preconditioning (RIPC)	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.

Primary Outcome Measures

Name	Time	Method
sustainability of Atrial Fibrillation measured in seconds	during the Atrial Fibrillation Ablation procedure
inducibility of Atrial Fibrillation by high-rate pacing of 20 s	during the Atrial Fibrillation Ablation procedure

Trial Locations

Locations (1)

Herzzentrum Leipzig; 🇩🇪 Leipzig, Germany