Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-04 @ 8:45 PM
Study NCT ID:
NCT02112318
Status:
TERMINATED
Last Update Posted:
2023-10-10
First Post:
2014-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CArdioversion of Short Duration Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D064752', 'term': 'Atrial Remodeling'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Opposite trend after interim analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-06', 'studyFirstSubmitDate': '2014-03-26', 'studyFirstSubmitQcDate': '2014-04-09', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Documentation of atrial fibrillation by ECG during follow up period after cardioversion', 'timeFrame': '6 weeks', 'description': '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'}]}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Electrocardiography', 'Electrical Remodeling']}, 'referencesModule': {'references': [{'pmid': '16956916', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23515337', 'type': 'BACKGROUND', 'citation': 'Choudhary 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.'}, {'pmid': '37480800', 'type': 'RESULT', 'citation': 'Holmqvist 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nEarlier 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.\n\nCASAF 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with recent onset persistent atrial fibrillation admitted for cardioversion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recurrent AF verified by at least one ECG recording prior to the index admission\n* Known onset of symptoms within 30 days from index admission.\n* Sinus rhythm ECG within 30 days prior to the index admission If onset of symptoms is unknown.\n* 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.\n* Echocardiography at any time since first onset of AF to verify the lack of significant valvular disease.\n* Age older than 18 years.\n\nExclusion Criteria:\n\n* AF due to reversible cause or significant valvular heart disease\n* Treatment with class I or III antiarrhythmic drugs within five half-lives of their elimination period. No amiodarone treatment within six months before admission\n* Prior ablation of AF\n* Unability to verify onset of symptoms within 30 days prior to the index admission'}, 'identificationModule': {'nctId': 'NCT02112318', 'acronym': 'CASAF', 'briefTitle': 'CArdioversion of Short Duration Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Study of ECG-derived Atrial Fibrillatory Rate for Prediction of the Outcome of Cardioversion of Short Duration Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'CASAF20090610'}}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G5', 'city': 'Québec', 'country': 'Canada', 'facility': "l'Institut universitaire de cardiologie et de pneumologie de Québec", 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '291 85', 'city': 'Kristianstad', 'country': 'Sweden', 'facility': 'Kristianstad General Hospital', 'geoPoint': {'lat': 56.03129, 'lon': 14.15242}}, {'zip': '22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Skane University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Pyotr G Platonov, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}