CArdioversion of Short Duration Atrial Fibrillation (CASAF)

October 6, 2023 updated by: Region Skane

Study of ECG-derived Atrial Fibrillatory Rate for Prediction of the Outcome of Cardioversion of Short Duration Atrial Fibrillation

The study is aimed at testing the hypothesis whether atrial fibrillary rate (AFR), as a measure of atrial electrical remodeling assessed from surface ECG, is predictive of sinus rhythm maintenance after electrical cardioversion.

Earlier studies performed in a retrospective fashion suggested that high AFR exceeding 350-360 fibrillations per minute is an independent predictor of AF relapse after cardioversion, particularly in patients with duration of AF episode not exceeding 30 days, however this hypothesis has not been tested in a prospective study.

CASAF is an observational study that will enroll patients with short duration (< 30 days) AF admitted for electrical cardioversion. Admission ECG will be extracted in a digital format and processed off-line for estimation of AFR. AF relapse will be assessed during 6-weeks long follow-up period during which ECG control will be scheduled at week 1 and 6.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

32

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

  • Canada
      • Quebec City, Canada, G1V 4G5
        • l'Institut universitaire de cardiologie et de pneumologie de Québec
  • Sweden
      • Kristianstad, Sweden, 291 85
        • Kristianstad General Hospital
      • Lund, Sweden, 22185
        • Skane University Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with recent onset persistent atrial fibrillation admitted for cardioversion

Description

Inclusion Criteria:

  • Recurrent AF verified by at least one ECG recording prior to the index admission
  • Known onset of symptoms within 30 days from index admission.
  • Sinus rhythm ECG within 30 days prior to the index admission If onset of symptoms is unknown.
  • If duration of the present AF episode >48 hours then thromboembolic risk should be minimized by either verifying that the patient is adequately anticoagulated according to the hospital routine or TEE performed to verify the lack of contraindications for electrical cardioversion.
  • Echocardiography at any time since first onset of AF to verify the lack of significant valvular disease.
  • Age older than 18 years.

Exclusion Criteria:

  • AF due to reversible cause or significant valvular heart disease
  • Treatment with class I or III antiarrhythmic drugs within five half-lives of their elimination period. No amiodarone treatment within six months before admission
  • Prior ablation of AF
  • Unability to verify onset of symptoms within 30 days prior to the index admission

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Documentation of atrial fibrillation by ECG during follow up period after cardioversion
Time Frame: 6 weeks
Primary outcome measure in the CASAF study is the number of patients who had relapse of atrial fibrillation during follow up. Primary analysis will be based on assessment the value of the ECG-derived atrial fibrillary rate < vs >= 350 f.p.m. for prediction of atrial fibrillation relapse during follow up
6 weeks

Collaborators and Investigators

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

Sponsor

Region Skane

Investigators

  • Principal Investigator: Pyotr G Platonov, MD, PhD, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2013

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimated)

April 11, 2014

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASAF20090610

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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