Effect of Ischemic Preconditioning on Atrial Fibrillation After Electrocardioversion (PRECON-AF)

July 7, 2024 updated by: St. Josefs-Hospital Wiesbaden GmbH

Effect of Ischemic Preconditioning on Relapse of Nonvalvular 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Wiesbaden, Hessen, Germany, 65189
        • St. Josefs-Hospital Wiesbaden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Remote Ischemic Preconditioning
Remote ischemic preconditioining
Procedure: Remote ischemic preconditioning
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 Comparator: Control
Sham preconditioning
Procedure: Sham preconditioning
Inflation of a blood pressure cuff to pressure values ~ 10mmHg for 5 minutes followed by 5 minutes of reperfusion (3 times each) before electrocardioversion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with recurrence of atrial fibrillation 30 days after electrical cardioversion
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimum energy required for successful electrocardioversion (in Joule)
Time Frame: 30 days
30 days
Cumulative energy applied for successfull electrocardioversion (in Joule)
Time Frame: 30 days
30 days
Cumulative number of shocks delivered for successfull electrocardioversion
Time Frame: 30 days
30 days
Number of patients with short-term cardioversion success
Time Frame: 30 seconds
Sinus rhythm lasting > 30 seconds after electrocardioversion
30 seconds
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Josefs-Hospital Wiesbaden GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 7, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRECON

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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