Safety of Cardioversion of Acute Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT01380574
• Lead Sponsor: Turku University Hospital

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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-27
• Primary Completion: 2012-05
• Status Verified: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF	31 days

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Satakunta Central Hospital; 🇫🇮 Pori, Finland

Turku University Hospital; 🇫🇮 Turku, Finland