Text Size

Safety of Cardioversion of Acute Atrial Fibrillation (FinCV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Juhani Airaksinen, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01380574
First received: June 16, 2011
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safety of Cardioversion of Acute Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Incidence and predictors of thromboembolic complications, especially stroke, and death <31 days after cardioversion of acute AF [ Time Frame: 31 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of therapy non-responder and early recurrence of AF [ Time Frame: 31 days ] [ Designated as safety issue: No ]
  • Bleeding complications during the 31 days follow-up [ Time Frame: 31 days ] [ Designated as safety issue: Yes ]
  • Hemodynamic complications of cardioversion [ Time Frame: 31 days ] [ Designated as safety issue: Yes ]

Enrollment: 7700
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380574

Locations
Finland
Kuopio University Hospital
Kuopio, Finland, 70211
Satakunta Central Hospital
Pori, Finland, 28500
Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Juhani Airaksinen, Professor Turku University Hospital
  More Information

No publications provided

Responsible Party: Juhani Airaksinen, Professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01380574     History of Changes
Other Study ID Numbers: K23
Study First Received: June 16, 2011
Last Updated: June 26, 2012
Health Authority: Finland: Ministry of Social Affairs and Health
Finland: Ethics Committee

Keywords provided by Turku University Hospital:
atrial fibrillation
cardioversion
stroke
thromboembolism

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013