FINnish CardioVersion Study II

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02850679
• Lead Sponsor: University of Turku

Brief Summary

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.

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 Timeline

• Study Start: 2014-04
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-07
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-27
• Last Update Submitted: 2016-07-27
• Study First Posted: 2016-08-01
• Last Update Posted: 2016-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1342

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatal or Non-fatal Stroke/TIA	30 days

Secondary Outcome Measures

Name	Time	Method
Arrhythmic Complications	24 hours	bradyarrhythmias, ventricular tachycardia and ventricular fibrillation
Failure of Cardioversion	24 hours	Assessed at discharge
Recurrence of AF after ECV	30 days

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland