Predictors for Recurrence of Atrial Fibrillation After Electrical Cardioversion (PRE-ELECTRIC)

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.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation

• Study Type: Observational
• Enrollment (Anticipated): 270

Contacts and Locations

• Study Contact: Name: Arnljot Tveit, MD, PhD; Phone Number: 0047-97171773; Email: arnljot.tveit@vestreviken.no
• Study Contact Backup: Name: Mona Olufsen, RN; Phone Number: 0047-90637441; Email: mona.olufsen@vestreviken.no

Study Locations

• Norway
  • Bærum
    • Sandvika, Bærum, Norway, 1346
      • Recruiting
      • Bærum Hospital, Vestre Viken
      • Contact: Arnljot Tveit, MD, PhD; Phone Number: 0047-97171773; Email: arnljot.tveit@vestreviken.no
      • Contact: Elizabeth Lyster Andersen, MD; Phone Number: 0047-90882242; Email: ellyan@vestreviken.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation recurrence	ECG-documented atrial fibrillation recurrence after successful cardioversion	30 days after electrical cardioversion

Collaborators and Investigators

• Sponsor: Vestre Viken Hospital Trust
• Collaborators: Lund University; Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Electrical Cardioversion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: PRE-ELECTRIC 2017/1604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No