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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03346863
Other study ID # PRE-ELECTRIC 2017/1604
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date December 2023

Study information

Verified date April 2021
Source Vestre Viken Hospital Trust
Contact Arnljot Tveit, MD, PhD
Phone 0047-97171773
Email arnljot.tveit@vestreviken.no
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 270
Est. completion date December 2023
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients > 18 years referred for electrical cardioversion for persistent atrial fibrillation - Signed, informed consent Exclusion Criteria: - Patients < 18 years - Patients with paroxysmal atrial fibrillation - Patients unwilling to participate or without consent competence

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Bærum Hospital, Vestre Viken Sandvika Bærum

Sponsors (3)

Lead Sponsor Collaborator
Vestre Viken Hospital Trust Lund University, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Atrial fibrillation recurrence ECG-documented atrial fibrillation recurrence after successful cardioversion 30 days after electrical cardioversion
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