Safety of Cardioversion of Acute Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— FinCV  

Official title:

Safety of Cardioversion of Acute Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380574
• Other study ID #: K23
• Status: Completed
• Phase: N/A
• First received: June 16, 2011
• Last updated: June 26, 2012
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and HealthFinland: Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7700
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio
Finland	Satakunta Central Hospital	Pori
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	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