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

J

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

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

Trial contacts and locations

1

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Central trial contact

Jedrzej Kosiuk, MD

Data sourced from clinicaltrials.gov

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