Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT00915720
Status:
UNKNOWN
Last Update Posted:
2011-07-20
First Post:
2009-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implanted Loop Recorder Post Atrial Fibrillation Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-06-04', 'releaseDate': '2014-05-06'}], 'estimatedResultsFirstSubmitDate': '2014-05-06'}}, '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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2009-06-04', 'studyFirstSubmitQcDate': '2009-06-05', 'lastUpdatePostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence/Duration of atrial and tachyarrhythmias post AF ablation', 'timeFrame': '14 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Surgical Ablation', 'Implanted loop recorder', 'Atrial Fibrillation Ablation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a pilot study to determine if implanted loop recorders can more effectively monitor atrial fibrillation recurrence after atrial fibrillation ablation.', 'detailedDescription': 'Atrial Fibrillation (AF)is the most common arrhythmia and causes significant morbidity and mortality. Treatment for AF consists of medical therapy and ablation therapy. Medical therapies can help approximately 50% of patients, the rest must resort to ablation procedures.\n\nAblation procedures aim to isolate the pulmonary vein from the atrial tissue electrically and can be performed either endocardially through catheters inserted through the femoral veins or epicardially through a minimal lateral thoracotomy. Both procedures are accepted as standard of care.\n\nRecurrent AF after ablation therapy can be common and occurs in 50% of patients and could be in a form of short periods of AF or persistent AF with less or minimal symptoms. This is of significant clinical relevance as most of these AF episodes are not recognized and can lead to thromboembolic events such as stroke. However, techniques of surveillance of AF post ablation have been suboptimal. Physicians could use holter monitoring but this is limited to a short period of 24 - 48 hours. Event recorders which are external can be used but patients need to experience symptoms associated with the AF episodes in order to record the episodes.\n\nBetter AF monitoring techniques especially after AF ablation are necessary so that recognition of AF recurrence in these patient could be possible and timely anticoagulation therapy initiated may prevent strokes.\n\nThis pilot study involves implanting a loop recorder just under the skin to record cardiac rhythms 24 hours per day without any interaction by the patient. These devices are currently approved by the FDA for monitoring of syncope and will be implanted during the patients AF ablation surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing surgical atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing surgical atrial fibrillation ablation\n* Patients must be 18 years or older\n\nExclusion Criteria:\n\n* Patients unwilling to comply with the follow up schedule\n* Pregnant or breastfeeding patients\n* Patients currently participating in another study'}, 'identificationModule': {'nctId': 'NCT00915720', 'briefTitle': 'Implanted Loop Recorder Post Atrial Fibrillation Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Thoracic & Cardiovascular Healthcare Foundation'}, 'officialTitle': 'Implanted Loop Recorder Surveillance of Recurrent Atrial Fibrillation After Atrial Fibrillation Ablation', 'orgStudyIdInfo': {'id': 'ILR 1208'}}, 'contactsLocationsModule': {'locations': [{'zip': '48910', 'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'facility': 'Thoracic & Cardiovascular Healthcare Foundation', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}], 'overallOfficials': [{'name': 'John H Ip, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thoracic & Cardiovascular Healthcare Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thoracic & Cardiovascular Healthcare Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}, {'name': 'AtriCure, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'John H. Ip, MD FACC', 'oldOrganization': 'Thoracic & Cardiovascular Healthcare Foundation'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-05-06', 'type': 'RELEASE'}, {'date': '2014-06-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Nancy Miller, John Ip MD, Thoracic & Cardiovascular Healthcare Foundation'}}}}