NCT03346863

Brief Summary

In patients with persistent atrial fibrillation (AF), electrical cardioversion is very effective in restoring sinus rhythm if modern, biphasic cardioverters are used. However, approximately 50 per cent of the successfully cardioverted patients experience a recurrence of AF within a few weeks. Therefore, valid predictors for AF recurrence would be of great clinical relevance, to avoid unnecessary procedures. In the PRE-ELECTRIC study, we will investigate the predictive value of potential new biomarkers with respect to AF recurrence within 30 days after electrical cardioversion. We will investigate serum and plasma biomarkers, electrocardiological markers and echocardiographic variables in this respect. The study will be undertaken as a prospective cohort study at Bærum Hospital, Vestre Viken Hospital Trust, with national and international collaborators.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

4.1 years

First QC Date

November 14, 2017

Last Update Submit

April 30, 2021

Conditions

Keywords

Electrical Cardioversion

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation recurrence

    ECG-documented atrial fibrillation recurrence after successful cardioversion

    30 days after electrical cardioversion

Eligibility Criteria

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

Patients \> 18 years referred for electrical cardioversion for ECG-documented persistent atrial fibrillation.

You may qualify if:

  • Patients \> 18 years referred for electrical cardioversion for persistent atrial fibrillation
  • Signed, informed consent

You may not qualify if:

  • Patients \< 18 years
  • Patients with paroxysmal atrial fibrillation
  • Patients unwilling to participate or without consent competence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bærum Hospital, Vestre Viken

Sandvika, Bærum, 1346, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, EDTA Plasma, Citrated Plasma, EDTA Whole Blood

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 17, 2017

Study Start

November 1, 2017

Primary Completion

December 1, 2021

Study Completion

December 1, 2023

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations