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OpenTrials
Completed

NCT Number: NCT05342220

Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Josefs-Hospital Wiesbaden

Wiesbaden, Hesse, 65189, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ischemic preconditioning

Procedure

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)

Sham preconditioning

Procedure

Inflation of a blood pressure cuff to pressure values ~ 10mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion

Primary outcomes

  1. Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion

    Time frame: 30 days

Secondary outcomes

  1. Number of patients with short-term cardioversion success

    Time frame: 30 seconds

    Sinus rhythm lasting > 30 seconds after electrocardioversion

  2. Minimum energy required for successful electrocardioversion (in Joule)

    Time frame: 30 days

  3. Cumulative energy applied for successfull electrocardioversion (in Joule)

    Time frame: 30 days

  4. Cumulative number of shocks delivered for successfull electrocardioversion

    Time frame: 30 days

  5. Number of patients experiencing death from any cause, stroke /transient ischemic attack, relevant post-ECV arrhythmia and procedure-associated complications

    Time frame: 30 days

    Safety endpoint

Sponsors and collaborators

Lead sponsor

St. Josefs-Hospital Wiesbaden GmbH

Other

Registry information

Official study title

Effect of Ischemic Preconditioning on Relapse of Nonvalvular Atrial Fibrillation After Electrocardioversion

Acronym: PRECON-AF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2022
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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