Atrial FibrillationCASAFNCT02112318
CArdioversion of Short Duration Atrial Fibrillation
An observational study of Atrial Fibrillation and Electrocardiography, run by Region Skane at 3 sites in 2 countries.
Trial summary
The study is aimed at testing the hypothesis whether atrial fibrillary rate (AFR), as a measure of atrial electrical remodeling assessed from surface ECG, is predictive of sinus rhythm maintenance after electrical cardioversion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Electrocardiography, Electrical Remodeling
- How many people
- 32 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2013to Mar 2021
- 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 with recent onset persistent atrial fibrillation admitted for cardioversion
Who may be able to join
- Recurrent AF verified by at least one ECG recording prior to the index admission
- Known onset of symptoms within 30 days from index admission.
- Sinus rhythm ECG within 30 days prior to the index admission If onset of symptoms is unknown.
- If duration of the present AF episode >48 hours then thromboembolic risk should be minimized by either verifying that the patient is adequately anticoagulated according to the hospital routine or TEE performed to verify the lack of contraindications for electrical cardioversion.
- Echocardiography at any time since first onset of AF to verify the lack of significant valvular disease.
- Age older than 18 years.
Who cannot join
- AF due to reversible cause or significant valvular heart disease
- Treatment with class I or III antiarrhythmic drugs within five half-lives of their elimination period. No amiodarone treatment within six months before admission
- Prior ablation of AF
- Unability to verify onset of symptoms within 30 days prior to the index admission
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Sweden2 sites
Kristianstad General Hospital
Kristianstad, 291 85
Skane University Hospital
Lund, 22185
Canada1 site
l'Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V 4G5
About this study
Official title: Study of ECG-derived Atrial Fibrillatory Rate for Prediction of the Outcome of Cardioversion of Short Duration Atrial Fibrillation
The study is aimed at testing the hypothesis whether atrial fibrillary rate (AFR), as a measure of atrial electrical remodeling assessed from surface ECG, is predictive of sinus rhythm maintenance after electrical cardioversion.
Earlier studies performed in a retrospective fashion suggested that high AFR exceeding 350-360 fibrillations per minute is an independent predictor of AF relapse after cardioversion, particularly in patients with duration of AF episode not exceeding 30 days, however this hypothesis has not been tested in a prospective study.
CASAF is an observational study that will enroll patients with short duration (< 30 days) AF admitted for electrical cardioversion. Admission ECG will be extracted in a digital format and processed off-line for estimation of AFR. AF relapse will be assessed during 6-weeks long follow-up period during which ECG control will be scheduled at week 1 and 6.
- Medical subject headings
- Atrial Fibrillation, Atrial Remodeling
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of atrial fibrillation by ECG during follow up period after cardioversion
Primary outcome measure in the CASAF study is the number of patients who had relapse of atrial fibrillation during follow up. Primary analysis will be based on assessment the value of the ECG-derived atrial fibrillary rate < vs >= 350 f.p.m. for prediction of atrial fibrillation relapse during follow up
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2018
- Study completionMar 2021
Why it stopped: Opposite trend after interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pyotr G Platonov, MD, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112318
- Sponsor's protocol ID
- CASAF20090610
- Acronym
- CASAF
- Status last verified
- Oct 2023
- First submitted
- 26 Mar 2014
- Last updated
- 10 Oct 2023
- Results posted
- No
Publications
Holmqvist F, Stridh M, Waktare JE, Sornmo L, Olsson SB, Meurling CJ. Atrial fibrillatory rate and sinus rhythm maintenance in patients undergoing cardioversion of persistent atrial fibrillation. Eur Heart J. 2006 Sep;27(18):2201-7. doi: 10.1093/eurheartj/ehl098. Epub 2006 Sep 6.
PubMed 16956916Choudhary MB, Holmqvist F, Carlson J, Nilsson HJ, Roijer A, Platonov PG. Low atrial fibrillatory rate is associated with spontaneous conversion of recent-onset atrial fibrillation. Europace. 2013 Oct;15(10):1445-52. doi: 10.1093/europace/eut057. Epub 2013 Mar 20.
PubMed 23515337Holmqvist F, Seifert MB, Fagerstrom VL, Nault I, Ostenson S, Carlson J, Ekelund U, Platonov PG. Study of ECG-derived atrial fibrillatory rate for prediction of the outcome of cardioversion of short duration atrial fibrillation (CASAF). J Electrocardiol. 2023 Nov-Dec;81:20-22. doi: 10.1016/j.jelectrocard.2023.07.003. Epub 2023 Jul 14.
PubMed 37480800
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of ECG-derived Atrial Fibrillatory Rate for Prediction of the Outcome of Cardioversion of Short Duration Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02112318
- Acronym / sponsor ID
- CASAF / CASAF20090610
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Opposite trend after interim analysis
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 11 Apr 2014 (estimated)
- 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.
The study is aimed at testing the hypothesis whether atrial fibrillary rate (AFR), as a measure of atrial electrical remodeling assessed from surface ECG, is predictive of sinus rhythm maintenance after electrical cardioversion.
Earlier studies performed in a retrospective fashion suggested that high AFR exceeding 350-360 fibrillations per minute is an independent predictor of AF relapse after cardioversion, particularly in patients with duration of AF episode not exceeding 30 days, however this hypothesis has not been tested in a prospective study.
CASAF is an observational study that will enroll patients with short duration (< 30 days) AF admitted for electrical cardioversion. Admission ECG will be extracted in a digital format and processed off-line for estimation of AFR. AF relapse will be assessed during 6-weeks long follow-up period during which ECG control will be scheduled at week 1 and 6.
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 with recent onset persistent atrial fibrillation admitted for cardioversion
Key inclusion criteria (6 listed)
- Recurrent AF verified by at least one ECG recording prior to the index admission
- Known onset of symptoms within 30 days from index admission.
- Sinus rhythm ECG within 30 days prior to the index admission If onset of symptoms is unknown.
- If duration of the present AF episode >48 hours then thromboembolic risk should be minimized by either verifying that the patient is adequately anticoagulated according to the hospital routine or TEE performed to verify the lack of contraindications for electrical cardioversion.
- Echocardiography at any time since first onset of AF to verify the lack of significant valvular disease.
Key exclusion criteria (4 listed)
- AF due to reversible cause or significant valvular heart disease
- Treatment with class I or III antiarrhythmic drugs within five half-lives of their elimination period. No amiodarone treatment within six months before admission
- Prior ablation of AF
- Unability to verify onset of symptoms within 30 days prior to the index admission
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
Documentation of atrial fibrillation by ECG during follow up period after cardioversion
Time frame: 6 weeks
Primary outcome measure in the CASAF study is the number of patients who had relapse of atrial fibrillation during follow up. Primary analysis will be based on assessment the value of the ECG-derived atrial fibrillary rate < vs >= 350 f.p.m. for prediction of atrial fibrillation relapse during follow up
Results and safety
The study was stopped early (reason given: Opposite trend after interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Background: PubMed 16956916Holmqvist F, Stridh M, Waktare JE, Sornmo L, Olsson SB, Meurling CJ. Atrial fibrillatory rate and sinus rhythm maintenance in patients undergoing cardioversion of persistent atrial fibrillation. Eur Heart J. 2006 Sep;27(18):2201-7. doi: 10.1093/eurheartj/ehl098. Epub 2006 Sep 6.
- Background: PubMed 23515337Choudhary MB, Holmqvist F, Carlson J, Nilsson HJ, Roijer A, Platonov PG. Low atrial fibrillatory rate is associated with spontaneous conversion of recent-onset atrial fibrillation. Europace. 2013 Oct;15(10):1445-52. doi: 10.1093/europace/eut057. Epub 2013 Mar 20.
- Results publication: PubMed 37480800Holmqvist F, Seifert MB, Fagerstrom VL, Nault I, Ostenson S, Carlson J, Ekelund U, Platonov PG. Study of ECG-derived atrial fibrillatory rate for prediction of the outcome of cardioversion of short duration atrial fibrillation (CASAF). J Electrocardiol. 2023 Nov-Dec;81:20-22. doi: 10.1016/j.jelectrocard.2023.07.003. Epub 2023 Jul 14.
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Atrial Fibrillation (AF)
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.
Pyotr G Platonov, MD, PhD principal investigator
Lund University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Electrocardiography, run by Region Skane at 3 sites in 2 countries.
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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden, Canada. 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?
The study was stopped early (reason given: Opposite trend after interim analysis). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documentation of atrial fibrillation by ECG during follow up period after cardioversion (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02112318, which also lists 3 linked publications.
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 10 Oct 2023.