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Completed

NCT Number: NCT01380574

Safety of Cardioversion of Acute Atrial Fibrillation

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kuopio University Hospital, Kuopio, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF

    Time frame: 31 days

Secondary outcomes

  1. Number of therapy non-responder and early recurrence of AF

    Time frame: 31 days

  2. Bleeding complications during the 31 days follow-up

    Time frame: 31 days

  3. Hemodynamic complications of cardioversion

    Time frame: 31 days

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Acronym: FinCV

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2011
Registry last updated
Jun 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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