Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Remote ischemic preconditioning; Procedure: Sham preconditioning

• Registration Number: NCT05342220
• Lead Sponsor: St. Josefs-Hospital Wiesbaden GmbH

Brief Summary

Remote ischemic preconditioning is one way to influence the success of therapy in cardiovascular patients. By means of remote ischemic preconditioning the incidence of atrial fibrillation after cardiac surgery was reduced by 54%. The investigators aim to investigate the effect of ischemic preconditioning in an easy-to-perform protocol with regard to the recurrence of atrial fibrillation after electrical cardioversion.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-15
• Study First Posted: 2022-04-22
• Primary Completion: 2024-03-31
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-07
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• Patients with paroxysmal or persistent atrial fibrillation who give written informed consent to participate in the study
• Age > 18 years
• Consent capacity

Exclusion Criteria

• Age under 18 years
• Pregnancy
• Lack of consent capacity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Ischemic Preconditioning	Remote ischemic preconditioning	Remote ischemic preconditioining
Control	Sham preconditioning	Sham preconditioning

Primary Outcome Measures

Name	Time	Method
Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion	30 days

Secondary Outcome Measures

Name	Time	Method
Minimum energy required for successful electrocardioversion (in Joule)	30 days
Cumulative energy applied for successfull electrocardioversion (in Joule)	30 days
Number of patients with short-term cardioversion success	30 seconds	Sinus rhythm lasting \> 30 seconds after electrocardioversion
Cumulative number of shocks delivered for successfull electrocardioversion	30 days
Number of patients experiencing death from any cause, stroke /transient ischemic attack, relevant post-ECV arrhythmia and procedure-associated complications	30 days	Safety endpoint

Trial Locations

Locations (1)

St. Josefs-Hospital Wiesbaden; 🇩🇪 Wiesbaden, Hessen, Germany