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Completed

NCT Number: NCT02850679

FINnish CardioVersion Study II

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Turku University Hospital

Turku, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fatal or Non-fatal Stroke/TIA

    Time frame: 30 days

Secondary outcomes

  1. Arrhythmic Complications

    Time frame: 24 hours

    bradyarrhythmias, ventricular tachycardia and ventricular fibrillation

  2. Failure of Cardioversion

    Time frame: 24 hours

    Assessed at discharge

  3. Recurrence of AF after ECV

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Official study title

Finnish Elective Cardioversion for Persistent Atrial Fibrillation Study

Acronym: FinCV2

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 1, 2016
Registry last updated
Aug 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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