NCT02850679

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,342

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
Last Updated

August 1, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

July 26, 2016

Last Update Submit

July 27, 2016

Conditions

Atrial Fibrillation

Keywords

Atrial FibrillationCardioversion

Outcome Measures

Primary Outcomes (1)

  • Fatal or Non-fatal Stroke/TIA

    30 days

Secondary Outcomes (3)

  • Arrhythmic Complications

    24 hours

  • Failure of Cardioversion

    24 hours

  • Recurrence of AF after ECV

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1342 patients with 1998 elective cardioversions

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Juhani Airaksinen, Professor

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 26, 2016

First Posted

August 1, 2016

Study Start

April 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 1, 2016

Record last verified: 2016-07

Locations

FI(1)