NCT02911545

Brief Summary

Non-vitamin K oral anticoagulants (NOAC) have been shown to be safe and effective alternatives to warfarin for stroke prevention in patients with nonvalvular AF (NVAF). There are yet limited real life data on outcomes following elective cardioversion in AF patients treated with NOACs. The aim of this study is to investigate the complications and the use of NOACs in AF patients undergoing cardioversion.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

4.2 years

First QC Date

September 16, 2016

Last Update Submit

September 21, 2016

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillationAnticoagulationCardioversion

Outcome Measures

Primary Outcomes (2)

  • Incidence and predictors of thromboembolic complications

    31 days after cardioversion of persistent AF

  • Incidence and predictors of bleeding

    31 days after cardioversion of persistent AF

Secondary Outcomes (2)

  • Number of recurrence of AF

    31 days after cardioversion of persistent AF

  • Hemodynamic complications of cardioversion

    31 days after cardioversion of persistent AF

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

AF patients undergoing cardioversion.

You may qualify if:

  • AF patients undergoing cardioversion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mika Lehto, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, cardiologist

Study Record Dates

First Submitted

September 16, 2016

First Posted

September 22, 2016

Study Start

October 1, 2011

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

September 22, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share