FINnish CardioVersion Study II (FinCV2)

July 27, 2016 updated by: Juhani Airaksinen, University of Turku

Finnish Elective Cardioversion for Persistent Atrial Fibrillation Study

This is a retrospective multi-center patient cohort study investigating patients with persistent atrial fibrillation (AF) and elective cardioversion (ECV). The aim is to identify clinical predictors for ineffective ECV to improve management quality of persistent AF.

Study Overview

Status

Completed

Conditions

Detailed Description

Data was gathered from patient registries of two finnish university hospitals and two regional hospitals in a time period of 2003-2015. A data search was conducted using the ICD-10 code for atrial fibrillation and NCSP code for cardioversion. All patients with AF and performed cardioversion were eligible for the study.

Initially, 2373 patients were captured after which all ECV cases were identified and included manually in the study using a structured electronic case report form. The study cohort comprised 1998 ECVs and 1342 patients. Follow-up data was gathered for 30 days after ECV and all strokes, transient ischemic attacks, arrhythmic complications, AF recurrences and failed cardioversions were recorded and subjected to careful exploration. IBM SPSS Statistics software version 22.0 was used to perform all analyses.

Study Type

Observational

Enrollment (Actual)

1342

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

1342 patients with 1998 elective cardioversions

Description

Inclusion Criteria:

  • All patients with persistent (>48h) atrial fibrillation and elective electrical cardioversion

Exclusion Criteria:

  • Cardioversions for patients with acute (<48h) atrial fibrillation
  • Pharmacological cardioversions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fatal or Non-fatal Stroke/TIA
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arrhythmic Complications
Time Frame: 24 hours
bradyarrhythmias, ventricular tachycardia and ventricular fibrillation
24 hours
Failure of Cardioversion
Time Frame: 24 hours
Assessed at discharge
24 hours
Recurrence of AF after ECV
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Investigators

  • Principal Investigator: Juhani Airaksinen, Professor, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

July 27, 2016

First Posted (Estimate)

August 1, 2016

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T118/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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