NCT01380574

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 28, 2012

Status Verified

June 1, 2012

Enrollment Period

11 months

First QC Date

June 16, 2011

Last Update Submit

June 26, 2012

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationcardioversionstrokethromboembolism

Outcome Measures

Primary Outcomes (1)

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

    31 days

Secondary Outcomes (3)

  • Number of therapy non-responder and early recurrence of AF

    31 days

  • Bleeding complications during the 31 days follow-up

    31 days

  • Hemodynamic complications of cardioversion

    31 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted \<48 from the beginning of the symptoms

You may not qualify if:

  • duration of the AF is unknown or \>48 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kuopio University Hospital

Kuopio, 70211, Finland

Location

Satakunta Central Hospital

Pori, 28500, Finland

Location

Turku University Hospital

Turku, 20520, Finland

Location

Related Publications (4)

  • Jaakkola S, Nuotio I, Hartikainen JEK, Airaksinen KEJ. Early Cardioversion for Acute Atrial Fibrillation in Low Stroke Risk Patients Is Safe Without Anticoagulation. J Am Coll Cardiol. 2020 Jul 14;76(2):226-227. doi: 10.1016/j.jacc.2020.04.076. No abstract available.

    PMID: 32646574DERIVED

  • Jaakkola J, Hartikainen JE, Kiviniemi T, Nuotio I, Nammas W, Gronberg T, Karmi A, Ylitalo A, Airaksinen KE. Ventricular rate during acute atrial fibrillation and outcome of electrical cardioversion: The FinCV Study. Ann Med. 2015 Jun;47(4):341-5. doi: 10.3109/07853890.2015.1031821. Epub 2015 May 6.

    PMID: 25943162DERIVED

  • Nuotio I, Hartikainen JE, Gronberg T, Biancari F, Airaksinen KE. Time to cardioversion for acute atrial fibrillation and thromboembolic complications. JAMA. 2014 Aug 13;312(6):647-9. doi: 10.1001/jama.2014.3824. No abstract available.

    PMID: 25117135DERIVED

  • Airaksinen KE, Gronberg T, Nuotio I, Nikkinen M, Ylitalo A, Biancari F, Hartikainen JE. Thromboembolic complications after cardioversion of acute atrial fibrillation: the FinCV (Finnish CardioVersion) study. J Am Coll Cardiol. 2013 Sep 24;62(13):1187-92. doi: 10.1016/j.jacc.2013.04.089. Epub 2013 Jul 10.

    PMID: 23850908DERIVED

MeSH Terms

Conditions

Atrial FibrillationStrokeThromboembolism

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesEmbolism and Thrombosis

Study Officials

  • Juhani Airaksinen, Professor

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 27, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

June 28, 2012

Record last verified: 2012-06

Locations

FI(3)