Safety of Cardioversion of Acute Atrial Fibrillation "FinCV"

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Retrospective
  • Sampling: Non-Probability Sample

Trial 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF 31 days Yes
Secondary Number of therapy non-responder and early recurrence of AF 31 days No
Secondary Bleeding complications during the 31 days follow-up 31 days Yes
Secondary Hemodynamic complications of cardioversion 31 days Yes

Sponsors