Safety of Cardioversion of Acute Atrial Fibrillation

NCT ID: NCT01380574

Last Updated: 2012-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Juhani Airaksinen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juhani Airaksinen, Professor

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

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Kuopio University Hospital

Kuopio, , Finland

Site Status

Satakunta Central Hospital

Pori, , Finland

Site Status

Turku University Hospital

Turku, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 32646574 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25943162 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25117135 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23850908 (View on PubMed)

Other Identifiers

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K23

Identifier Type: -

Identifier Source: org_study_id

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