Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion
PRECON-AF
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 6, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJuly 9, 2024
July 1, 2024
2 years
April 6, 2022
July 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion
30 days
Secondary Outcomes (5)
Number of patients with short-term cardioversion success
30 seconds
Minimum energy required for successful electrocardioversion (in Joule)
30 days
Cumulative energy applied for successfull electrocardioversion (in Joule)
30 days
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
Study Arms (2)
Remote Ischemic Preconditioning
ACTIVE COMPARATORRemote ischemic preconditioining
Control
SHAM COMPARATORSham preconditioning
Interventions
Remote ischemic preconditioning through inflation of a blood pressure cuff to pressure values \> 200mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion Electrical cardioversion for atrial fibrillation (100, 150, 200 Joule)
Inflation of a blood pressure cuff to pressure values \~ 10mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion
Eligibility Criteria
You may qualify if:
- Patients with paroxysmal or persistent atrial fibrillation who give written informed consent to participate in the study
- Age \> 18 years
- Consent capacity
You may not qualify if:
- Age under 18 years
- Pregnancy
- Lack of consent capacity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Josefs-Hospital Wiesbaden
Wiesbaden, Hesse, 65189, Germany
Related Publications (1)
Keim C, Wiedenmann L, Schubert T, Rothe M, Dobre BC, Kaess BM, Ehrlich JR, Boehmer AA. Remote Ischemic Preconditioning for Electrical Cardioversion of Atrial Fibrillation-the Prospective Randomized PRECON-AF Study. CJC Open. 2025 Mar 10;7(5):571-578. doi: 10.1016/j.cjco.2025.03.004. eCollection 2025 May.
PMID: 40433224DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 6, 2022
First Posted
April 22, 2022
Study Start
April 1, 2022
Primary Completion
March 31, 2024
Study Completion
June 30, 2024
Last Updated
July 9, 2024
Record last verified: 2024-07