Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
Study NCT ID:
NCT04290559
Status:
UNKNOWN
Last Update Posted:
2020-03-31
First Post:
2020-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life
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': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-29', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-26', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AF burden correlated with change in QOL.', 'timeFrame': '12 months, 24 months', 'description': 'AF burden change and absolute AF burden correlated with change in QOL mesured at 12 and 24 months after the AF ablation'}], 'secondaryOutcomes': [{'measure': 'Freedom of atrial arrhythmia', 'timeFrame': '12 months, 24 months', 'description': 'Freedom of atrial tachycardia/atrial flutter/atrial fibrillation (\\> 30 sec) at 12 and 24 months after the ablation'}, {'measure': 'Economic evaluation', 'timeFrame': '12 months, 24 months', 'description': 'Change in AF burden correlated with change of health care resource utilization'}, {'measure': 'Incidence of silent AF recurrences', 'timeFrame': '12 months, 24 months', 'description': 'Total asymptomatic AF burden (Percent time in AF)'}, {'measure': 'Impact of antiarrhythmic treatment', 'timeFrame': '12 months', 'description': 'Compare quality of life on and off antiarrhythmic medications using 36-Item Short Form Survey (SF-36) scale: range 0-100, 100 is best.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Catheter ablation', 'Quality of life', 'Atrial fibrillation burden', 'Persistent atrial fibrillation'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the atrial fibrillation burden reduction, or absolute atrial fibrillation burden, associated with improvement in quality of life in patients undergoing ablation of persistent atrial fibrillation.', 'detailedDescription': 'Atrial fibrillation (AF) is associated with a higher risk of stroke, heart failure and deterioration in patients\' quality of life and it also has great effect on health care resource utilization due to increasing morbidity and mortality. Catheter ablation has shown to improve patients\' quality of life (QOL), even in those who undergo a repeat procedure, equalizing healthy population and lowering subsequent health care resource utilization.\n\nSuccess rates are usually based on an endpoint of total elimination of AF, typically absence of any AF recurrence \\>30 seconds. While this is a high standard for clinical trial reporting, it does not necessarily measure the "clinical" success, since many patients will experience significant reduction in their AF burden with accompanying improvement in their functional status despite having ongoing brief recurrences of AF.\n\nThis is a prospective non-randomized, single-arm, cohort study. 200 patients with persistent atrial fibrillation undergoing catheter ablation will be enroled. AF burden post procedure will be evaluated with continuous monitoring with an implantable loop recorder (ILR) to assess recurrences and AF burden. QOL will be measured using the CCS-SAF severity scale, SF-36 and AFEQT scales pre-ablation and at 12 and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with persistent or long-standing persistent atrial fibrillation and an AF burden of equal or more than 80%, referred for an atrial fibrillation catheter ablation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Patients undergoing first-time or redo AF ablation.\n* Persistent or long-standing persistent AF\n* Symptomatic atrial fibrillation\n* Willing and able to provide informed consent.\n* Willing and able to set up and utilize MyCareLink® home monitor and be remotely monitored\n* Atrial fibrillation burden equal or more than 80% prior to the ablation\n\nExclusion Criteria:\n\n* Paroxysmal AF\n* If the patient has had a cardioversion within 2 months of the ablation\n* Patients with contraindication to oral or intravenous anticoagulation.\n* Contraindication to implantation of an ILR'}, 'identificationModule': {'nctId': 'NCT04290559', 'acronym': 'LEARN-AF', 'briefTitle': 'Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'Newmarket Electrophysiology Research Group Inc'}, 'officialTitle': 'Long-term Monitoring After Persistent Atrial Fibrillation Ablation and Correlation to Quality of Life', 'orgStudyIdInfo': {'id': 'NERG-04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Reveal LINQ ILR implant before AF ablation', 'type': 'PROCEDURE', 'description': 'Patients will undergo insertion of a LINQ ILR before the atrial fibrillation ablation performed according to standard clinical practice.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L3Y2P9', 'city': 'Newmarket', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sherri Patterson, BScN', 'role': 'CONTACT', 'email': 'SPatterson@southlakeregional.org', 'phone': '905-895-4521', 'phoneExt': '2149'}], 'facility': 'Southlake Regional Health Centre', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}], 'centralContacts': [{'name': 'Sherri Patterson, BScN', 'role': 'CONTACT', 'email': 'SPatterson@southlakeregional.org', 'phone': '905-895-4521', 'phoneExt': '2149'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Newmarket Electrophysiology Research Group Inc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}