Clinical trial NCT02112318: CArdioversion of Short Duration Atrial Fibrillation
Official title: Study of ECG-derived Atrial Fibrillatory Rate for Prediction of the Outcome of Cardioversion of Short Duration Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Atrial Fibrillation
Electrocardiography
Electrical Remodeling
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with recent onset persistent atrial fibrillation admitted for cardioversion

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Documentation of atrial fibrillation by ECG during follow up period after cardioversion
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: l'Institut universitaire de cardiologie et de pneumologie de Québec
city: Kristianstad
country: Sweden
facility: Kristianstad General Hospital
city: Lund
country: Sweden
facility: Skane University Hospital
Study officials:
affiliation: Lund University
name: Pyotr G Platonov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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. 2023 Nov-Dec;81:20-22. doi: 10.1016/j.jelectrocard.2023.07.003. Epub 2023 Jul 14.