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Safety of Cardioversion of Acute Atrial Fibrillation

Safety of Cardioversion of Acute Atrial Fibrillation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01380574
Acronym
FinCV
Enrollment
7700
Registered
2011-06-27
Start date
2011-06-30
Completion date
2012-06-30
Last updated
2012-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, cardioversion, stroke, thromboembolism

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.

Interventions

None listed

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF31 days

Secondary

MeasureTime frame
Number of therapy non-responder and early recurrence of AF31 days
Bleeding complications during the 31 days follow-up31 days
Hemodynamic complications of cardioversion31 days

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026