NCT05926401

Brief Summary

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.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Typical duration 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

First Submitted

Initial submission to the registry

June 22, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

June 22, 2023

Last Update Submit

November 27, 2023

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • The rate of spontaneously conversion to SR in patients with AF scheduled for elective cardioversion

    10 days pre/post cardioversion

  • The rate of early recurrence (<5 days) of AF after elective cardioversion

    up to 5 days pre/post cardioversion

Study Arms (1)

Planned elective cardioversion for atrial fibrillation

Other: ECG monitoring prior and after cardioversion

Interventions

ECG monitoring prior and after cardioversionOTHER

Continuous ECG monitoring at home 3-5 days prior to and 5-7 days after planned cardioversion

Planned elective cardioversion for atrial fibrillation

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sorlandet Hospital

Arendal, Norway

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sigrun Halvorsen, PhD

    Oslo university hospital /University of Oslo

    STUDY CHAIR

Central Study Contacts

Jarle Jortveit, PhD

CONTACT

+4799450714jarle.jortveit@sshf.no

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 3, 2023

Study Start

September 1, 2023

Primary Completion

June 30, 2024

Study Completion

December 31, 2025

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)