Atrial Fibrillation Prior and Post Elective Cardioversion

November 27, 2023 updated by: Sorlandet Hospital HF
Cardioversion from atrial fibrillation (AF) to sinus rhythm (SR) is performed primarily to improve patient symptoms. However, due to the intermittent nature of AF, patients may have converted to SR prior to elective cardioversion and the recurrence rate of AF after cardioversion can be high. The aims of this study are to assess the rate of spontaneously conversion to SR in patients with AF scheduled for elective cardioversion, as well as the rate of early recurrence of AF after elective cardioversion.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients satisfying the inclusion criteria will be recruited after informed written consent for study participation.

Description

Inclusion Criteria:

  • Planned elective cardioversion of AF
  • Informed written consent for participation

Exclusion Criteria:

  • Lack of ability to cooperate
  • Pacemaker/CRT device
  • No smart phone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Planned elective cardioversion for atrial fibrillation
Other: ECG monitoring prior and after cardioversion
Continuous ECG monitoring at home 3-5 days prior to and 5-7 days after planned cardioversion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of spontaneously conversion to SR in patients with AF scheduled for elective cardioversion
Time Frame: 10 days pre/post cardioversion
10 days pre/post cardioversion
The rate of early recurrence (<5 days) of AF after elective cardioversion
Time Frame: up to 5 days pre/post cardioversion
up to 5 days pre/post cardioversion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorlandet Hospital HF

Collaborators

Oslo University Hospital

Investigators

  • Study Chair: Sigrun Halvorsen, PhD, Oslo university hospital /University of Oslo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

June 29, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 543834

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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