CArdioversion of Short Duration Atrial Fibrillation

NCT02112318 | Terminated

• 1 other identifier: CASAF20090610
• Study Type: observational
• Target: 32
• Locations: 2 countries
• Sites: 3

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.

Conditions

Atrial Fibrillation; Electrocardiography; Electrical Remodeling

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with recent onset persistent atrial fibrillation admitted for cardioversion

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (3)

l'Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

Location

Kristianstad General Hospital

Kristianstad, 291 85, Sweden

Location

Skane University Hospital

Lund, 22185, Sweden

Location

Related Publications (3)

• 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.

  PMID: 16956916 BACKGROUND

• 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.

  PMID: 23515337 BACKGROUND

• 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.

  PMID: 37480800 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Remodeling

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• Pyotr G Platonov, MD, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2014
• First Posted: April 11, 2014
• Study Start: January 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2021
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

CA (1); SE (2)