Clinical trial NCT01380574: Safety of Cardioversion of Acute Atrial Fibrillation
Official title: Safety of Cardioversion of Acute Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
cardioversion
stroke
thromboembolism
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2011-06-27
Enrollment: 7700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted \<48 from the beginning of the symptoms.

Brief summary: The purpose of this study is to investigate the complications of cardioversion of acute (\<48 hours duration) atrial fibrillation (AF).

Primary Outcome Measures:

- Incidence and predictors of thromboembolic complications, especially stroke, and death \<31 days after cardioversion of acute AF

Secondary Outcome Measures:

* Number of therapy non-responder and early recurrence of AF
* Bleeding complications during the 31 days follow-up
* Hemodynamic complications of cardioversion

Estimated Enrollment: 3000 cases

Study Start Date: Jun 2011

Estimated Study Completion Date: December 2011

Detailed description: It has been a common practice to perform cardioversion of acute (\<48 hour) AF without any anticoagulation. The new European guidelines recommend that anticoagulation should be started already before cardioversion in all patients with CHADS2VASC score indicating need for long-term oral anticoagulation. The evidence behind these guidelines is, however, scarce. In this retrospective study we collect data on the safety of acute AF cardioversion from emergency rooms of two university hospitals and one secondary referral center from the years 2003-2010.

Inclusion criteria:

All patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted \<48 from the beginning of the symptoms.

Eligibility criteria: Inclusion Criteria:

* patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted \<48 from the beginning of the symptoms

Exclusion Criteria:

* duration of the AF is unknown or \>48 hours

Primary outcomes:
measure: Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF
timeFrame: 31 days
Secondary outcomes:
measure: Number of therapy non-responder and early recurrence of AF
timeFrame: 31 days
measure: Bleeding complications during the 31 days follow-up
timeFrame: 31 days
measure: Hemodynamic complications of cardioversion
timeFrame: 31 days
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Pori
country: Finland
facility: Satakunta Central Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Juhani Airaksinen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jaakkola S, Nuotio I, Hartikainen JEK, Airaksinen KEJ. Early Cardioversion for Acute Atrial Fibrillation in Low Stroke Risk Patients Is Safe Without Anticoagulation. J Am Coll Cardiol. 2020 Jul 14;76(2):226-227. doi: 10.1016/j.jacc.2020.04.076. No abstract available.
citation: Jaakkola J, Hartikainen JE, Kiviniemi T, Nuotio I, Nammas W, Gronberg T, Karmi A, Ylitalo A, Airaksinen KE. Ventricular rate during acute atrial fibrillation and outcome of electrical cardioversion: The FinCV Study. Ann Med. 2015 Jun;47(4):341-5. doi: 10.3109/07853890.2015.1031821. Epub 2015 May 6.
citation: Nuotio I, Hartikainen JE, Gronberg T, Biancari F, Airaksinen KE. Time to cardioversion for acute atrial fibrillation and thromboembolic complications. JAMA. 2014 Aug 13;312(6):647-9. doi: 10.1001/jama.2014.3824. No abstract available.
citation: Airaksinen KE, Gronberg T, Nuotio I, Nikkinen M, Ylitalo A, Biancari F, Hartikainen JE. Thromboembolic complications after cardioversion of acute atrial fibrillation: the FinCV (Finnish CardioVersion) study. J Am Coll Cardiol. 2013 Sep 24;62(13):1187-92. doi: 10.1016/j.jacc.2013.04.089. Epub 2013 Jul 10.