Atrial FibrillationNCT05926401
Atrial Fibrillation Prior and Post Elective Cardioversion
An observational study of Atrial Fibrillation, run by Sorlandet Hospital HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ECG monitoring prior and after cardioversion
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients satisfying the inclusion criteria will be recruited after informed written consent for study participation.
Who may be able to join
- Planned elective cardioversion of AF
- Informed written consent for participation
Who cannot join
- Lack of ability to cooperate
- Pacemaker/CRT device
- No smart phone
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Sorlandet Hospital
Arendal
Jarle Jortveit, PhD, jarle.jortveit@sshf.no
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- ECG monitoring prior and after cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG monitoring prior and after cardioversionOther
Continuous ECG monitoring at home 3-5 days prior to and 5-7 days after planned cardioversion
| Study group | Role | What they receive |
|---|---|---|
| Planned elective cardioversion for atrial fibrillation | Not described Receives: Other: ECG monitoring prior and after cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of spontaneously conversion to SR in patients with AF scheduled for elective cardioversion
Measured: 10 days pre/post cardioversion
The rate of early recurrence (<5 days) of AF after elective cardioversion
Measured: up to 5 days pre/post cardioversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Sep 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Sigrun Halvorsen, PhD, Study chair, Oslo university hospital /University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926401
- Sponsor's protocol ID
- 543834
- Status last verified
- Nov 2023
- First submitted
- 22 Jun 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation Prior and Post Elective Cardioversion
- ClinicalTrials.gov ID
- NCT05926401
- Acronym / sponsor ID
- 543834
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Oslo University Hospital
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Planned elective cardioversion for atrial fibrillation | – | Other: ECG monitoring prior and after cardioversion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients satisfying the inclusion criteria will be recruited after informed written consent for study participation.
Key inclusion criteria (2 listed)
- Planned elective cardioversion of AF
- Informed written consent for participation
Key exclusion criteria (3 listed)
- Lack of ability to cooperate
- Pacemaker/CRT device
- No smart phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG monitoring prior and after cardioversionContinuous ECG monitoring at home 3-5 days prior to and 5-7 days after planned cardioversion | Other | Planned elective cardioversion for atrial fibrillation |
Primary outcome
The rate of spontaneously conversion to SR in patients with AF scheduled for elective cardioversion
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sigrun Halvorsen, PhD study chair
Oslo university hospital /University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jarle Jortveit, PhD (+4799450714, jarle.jortveit@sshf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of spontaneously conversion to SR in patients with AF scheduled for elective cardioversion (time frame: 10 days pre/post cardioversion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.