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

Jedrzej Kosiuk

Status: Unknown

Conditions: Atrial Fibrillation

Treatments: Procedure: sham-intervention; Procedure: Remote ischemic preconditioning (RIPC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02779660

RIPPAF V1

Details and patient eligibility

About

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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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146 participants in 2 patient groups, including a placebo group

RIPC-Group

Experimental group

Description:

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.

Treatment:

Procedure: Remote ischemic preconditioning (RIPC)

Control-Group

Placebo Comparator group

Description:

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.

Treatment:

Procedure: sham-intervention