Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-27 @ 10:32 AM
Study NCT ID:
NCT01530750
Status:
UNKNOWN
Last Update Posted:
2012-09-03
First Post:
2012-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
READ-POAF Pilot Studies Postoperative Atrial Fibrillation After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-31', 'studyFirstSubmitDate': '2012-02-08', 'studyFirstSubmitQcDate': '2012-02-09', 'lastUpdatePostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'atrial fibrillation (AF)', 'timeFrame': '3 months', 'description': 'frequency, frequency distribution, and burden of AF'}], 'secondaryOutcomes': [{'measure': 'atrial fibrillation (AF)', 'timeFrame': '12 months', 'description': 'frequency, frequency distribution, burden of AF, AF substrate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postoperative atrial fibrillation', 'internal loop recorder', 'risk factors', 'coronary artery bypass surgery'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '34198338', 'type': 'DERIVED', 'citation': 'Bidar E, Zeemering S, Gilbers M, Isaacs A, Verheule S, Zink MD, Maesen B, Bramer S, Kawczynski M, Van Gelder IC, Crijns HJGM, Maessen JG, Schotten U. Clinical and electrophysiological predictors of device-detected new-onset atrial fibrillation during 3 years after cardiac surgery. Europace. 2021 Dec 7;23(12):1922-1930. doi: 10.1093/europace/euab136.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative atrial fibrillation after coronary artery bypass grafting will be monitored up to 1 year after the procedure by implanting a Reveal XT internal loop recorder two weeks before the surgery. Frequency, burden, and possible risk factors will be described.\n\nDuring the operation direct contact epicardial mapping will be performed and tissue samples will be collected to identify an electrophysiological and a structural substrate for development of AF.', 'detailedDescription': 'Background of the study:\n\nPostoperative atrial fibrillation (POAF) after cardiac surgery is a common (1 in 4) complication and associated with morbidity and mortality. Not all episodes of AF are noticed and detected, especially after discharge. several studies have shown high mortality in POAF patients, suggesting a progression in AF frequency.\n\nObjective of the study:\n\nTo investigate the real incidence and burden of POAF. Afterwards a risk stratification of POAF is made. To identify a structural and electrophysiological substrate for the development of POAF and new onset AF during follow up.\n\nStudy design:\n\n140 patients will receive a Reveal device. After 3 and 12 months data will be subtracted from the device. 100 of these patient will undergo additional mapping and tissue biopsies during operation.\n\nStudy population:\n\nAll patients undergoing cardiac surgery without a history of AF and without a pacemaker will be invited to participate in the study.\n\nPrimary study parameters/outcome of the study:\n\nIncidence of POAF until 3 months after CABG.\n\nSecondary study parameters/outcome of the study:\n\nIncidence of POAF until 12 months after CABG. Determine risk factors for early and late POAF. Detect pre-operative (unnoticed) episodes of AF.\n\nDetermine a substrate for development of AF.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness:\n\nThere is a small risk of minor complications (hemorrhage and infection of the pocket).The device can be explanted easily if necessary. Ther is a burden of the im- and explantation of the device (local anesthesia, approx. 20 minutes). Patient will have to visit the out-hospital clinic twice.\n\nThe operation will be prolonged by 30 minutes due to mapping.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'those patients undergoing cardiac surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing non emergency surgery\n* Sinus rhythm on initial visit\n\nExclusion Criteria:\n\n* History of atrial fibrillation\n* Internal pacemaker'}, 'identificationModule': {'nctId': 'NCT01530750', 'briefTitle': 'READ-POAF Pilot Studies Postoperative Atrial Fibrillation After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': 'READ-POAF Pilot Study. The Use of the Reveal XT as Device for Postoperative Atrial Fibrillation Detection After Cardiac Surgery', 'orgStudyIdInfo': {'id': 'NL37204.060.11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Post cardiac surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Eindhoven', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bramer', 'role': 'CONTACT', 'email': 'sander.bramer@cze.nl'}], 'facility': 'Catharina Hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Maastricht', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bramer', 'role': 'CONTACT', 'email': 'sander.bramer@cze.nl'}], 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Sander Bramer, MD', 'role': 'CONTACT', 'email': 'sander.bramer@cze.nl', 'phone': '+31402398680'}], 'overallOfficials': [{'name': 'Bart van Straten, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CZE'}, {'name': 'Sander Bramer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CZE'}, {'name': 'Jos Maessen, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maastricht University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}