Clinical Trials Directory

Trials / Completed

CompletedNCT01380574

Safety of Cardioversion of Acute Atrial Fibrillation

Status
Completed
Phase
Study type
Observational
Enrollment
7,700 (actual)
Sponsor
Turku University Hospital · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2011-06-01
Primary completion
2012-05-01
Completion
2012-06-01
First posted
2011-06-27
Last updated
2012-06-28

Locations

3 sites across 1 country: Finland

Source: ClinicalTrials.gov record NCT01380574. Inclusion in this directory is not an endorsement.