FINnish CardioVersion Study II

Finnish Elective Cardioversion for Persistent Atrial Fibrillation Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02850679

Acronym

FinCV2

Enrollment

1342

Registered

2016-08-01

Start date

2014-04-30

Completion date

2016-01-31

Last updated

2016-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation, Cardioversion

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Fatal or Non-fatal Stroke/TIA	30 days

Secondary

Measure	Time frame	Description
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	—

Countries

Finland

Outcome results