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Status unknownNCT03346863PRE-ELECTRICUpdated May 3, 2021

Predictors for Recurrence of Atrial Fibrillation After Electrical Cardioversion

An observational study in Atrial Fibrillation, sponsored by Vestre Viken Hospital Trust. Status unknown at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-03.

Sponsored by Vestre Viken Hospital Trust · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
270
Ages
18 Years and older
Sex
All
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Study 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.

02

Conditions studied

  • Atrial Fibrillation

Keywords

  • Electrical Cardioversion
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
270 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Atrial fibrillation recurrence

    ECG-documented atrial fibrillation recurrence after successful cardioversion

    Time frame: 30 days after electrical cardioversion

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03346863
Lead sponsor
Vestre Viken Hospital Trust
Collaborators
Oslo University Hospital, Lund University
Responsible party
Sponsor
First posted
Nov 17, 2017
Start date
Nov 1, 2017
Primary completion
Dec 2021 (estimated)
Completion
Dec 2023 (estimated)
Last update
May 3, 2021

Study contacts

Arnljot Tveit, MD, PhD
Contact
arnljot.tveit@vestreviken.no
0047-97171773
Mona Olufsen, RN
Contact
mona.olufsen@vestreviken.no
0047-90637441

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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