Atrial FibrillationPRE-ELECTRICNCT03346863
Predictors for Recurrence of Atrial Fibrillation After Electrical Cardioversion
An observational study of Atrial Fibrillation, run by Vestre Viken Hospital Trust at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 270 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2017to Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients > 18 years referred for electrical cardioversion for ECG-documented persistent atrial fibrillation.
Who may be able to join
- Patients > 18 years referred for electrical cardioversion for persistent atrial fibrillation
- Signed, informed consent
Who cannot join
- Patients < 18 years
- Patients with paroxysmal atrial fibrillation
- Patients unwilling to participate or without consent competence
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Bærum Hospital, Vestre Viken
Sandvika, Bærum, 1346
Arnljot Tveit, MD, PhD, 0047-97171773, arnljot.tveit@vestreviken.no
Elizabeth Lyster Andersen, MD, 0047-90882242, ellyan@vestreviken.no
About this study
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.
- Conditions
- Atrial Fibrillation
- Keywords
- Electrical Cardioversion
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation recurrence
ECG-documented atrial fibrillation recurrence after successful cardioversion
Measured: 30 days after electrical cardioversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Nov 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2023 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Lund University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346863
- Sponsor's protocol ID
- PRE-ELECTRIC 2017/1604
- Acronym
- PRE-ELECTRIC
- Status last verified
- Apr 2021
- First submitted
- 14 Nov 2017
- Last updated
- 3 May 2021
- 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 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors for Recurrence of Atrial Fibrillation After Electrical Cardioversion
- ClinicalTrials.gov ID
- NCT03346863
- Acronym / sponsor ID
- PRE-ELECTRIC / PRE-ELECTRIC 2017/1604
- Conditions
- Atrial Fibrillation
- Keywords
- Electrical Cardioversion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Lund University
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 17 Nov 2017 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients > 18 years referred for electrical cardioversion for ECG-documented persistent atrial fibrillation.
Key inclusion criteria (2 listed)
- Patients > 18 years referred for electrical cardioversion for persistent atrial fibrillation
- Signed, informed consent
Key exclusion criteria (3 listed)
- Patients < 18 years
- Patients with paroxysmal atrial fibrillation
- Patients unwilling to participate or without consent competence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atrial fibrillation recurrence
Time frame: 30 days after electrical cardioversion
ECG-documented atrial fibrillation recurrence after successful cardioversion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- 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.
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 Vestre Viken Hospital Trust 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 3 May 2021. 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 Arnljot Tveit, MD, PhD (0047-97171773, arnljot.tveit@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation recurrence (time frame: 30 days after electrical cardioversion). 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 3 May 2021.