CArdioversion of Short Duration Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— CASAF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02112318
• Other study ID #: CASAF20090610
• Status: Terminated
• Start date: January 2013
• Est. completion date: March 2021

Study information

• Verified date: October 2023
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: March 2021
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Remodeling
• Electrical Remodeling
• Electrocardiography

Locations

Country	Name	City	State
Canada	l'Institut universitaire de cardiologie et de pneumologie de Québec	Quebec City
Sweden	Kristianstad General Hospital	Kristianstad
Sweden	Skane University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Countries where clinical trial is conducted

Canada,  Sweden, 

References & Publications (3)

Choudhary MB, Holmqvist F, Carlson J, Nilsson HJ, Roijer A, Platonov PG. Low atrial fibrillatory rate is associated with spontaneous conversion of recent-onset atrial fibrillation. Europace. 2013 Oct;15(10):1445-52. doi: 10.1093/europace/eut057. Epub 2013 Mar 20. — View Citation

Holmqvist F, Seifert MB, Fagerstrom VL, Nault I, Ostenson S, Carlson J, Ekelund U, Platonov PG. Study of ECG-derived atrial fibrillatory rate for prediction of the outcome of cardioversion of short duration atrial fibrillation (CASAF). J Electrocardiol. 2 — View Citation

Holmqvist F, Stridh M, Waktare JE, Sornmo L, Olsson SB, Meurling CJ. Atrial fibrillatory rate and sinus rhythm maintenance in patients undergoing cardioversion of persistent atrial fibrillation. Eur Heart J. 2006 Sep;27(18):2201-7. doi: 10.1093/eurheartj/ehl098. Epub 2006 Sep 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation of atrial fibrillation by ECG during follow up period after cardioversion	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