Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-30 @ 12:21 PM
Study NCT ID:
NCT06155357
Status:
WITHDRAWN
Last Update Posted:
2024-12-04
First Post:
2023-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of a Lifestyle Program on Recurrent Atrial Fibrillation
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2023-11-24', 'studyFirstSubmitQcDate': '2023-12-01', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Cardiac Rehab Sessions Attended', 'timeFrame': '12 weeks', 'description': 'Number of cardiac rehab sessions attended during the 12-week multicomponent lifestyle intervention program.'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with Atrial Fibrillation (AF) recurrence', 'timeFrame': '1 year', 'description': 'Number of subjects with AF recurrence will be assessed by chart review and clinically indicated holter monitor.'}, {'measure': 'Change in weight loss', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Change in weight loss pre \\& post multicomponent lifestyle intervention program reported in kilograms (kg)'}, {'measure': 'Change in exercise capacity', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Change in exercise capacity will be assessed by 6-minute walk test pre \\& post multicomponent lifestyle intervention program. Measurement (meters) of distance a person can walk on flat ground in 6 minutes.'}, {'measure': 'Change in Atrial Fibrillation (AF) Symptom severity', 'timeFrame': 'Baseline, 12 weeks, 6 months, 1 year', 'description': 'Change in AF Symptom Severity will be assessed by the Atrial Fibrillation Severity Scale (AFSS) questionnaire. The AFSS questionnaire is a 19-item self-administered questionnaire developed to capture subjective and objective ratings of AF related symptoms, health care utilization, and AF disease burden, including frequency, duration, and severity of episodes. Higher scores indicate higher symptom severity (range of 0-35).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the impact of a comprehensive lifestyle intervention, including cardiac rehabilitation, prior to catheter ablation (a procedure to stop abnormal electrical signals in the heart), on Atrial Fibrillation (AF)-related symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Paroxysmal or persistent atrial fibrillation.\n* Planned elective catheter ablation of AF.\n\nExclusion Criteria:\n\n* Prior catheter ablation.\n* Presence of pacemaker/ICD.\n* Longstanding persistent AF.\n* Uncontrolled AF (including poor rate control or tachycardia-mediated cardiomyopathy requiring urgent cardioversion/ablation at the clinician's assessment)."}, 'identificationModule': {'nctId': 'NCT06155357', 'briefTitle': 'A Study of a Lifestyle Program on Recurrent Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Pre-habilitation Multicomponent Lifestyle Program for Patients Undergoing Ablation for Atrial Fibrillation', 'orgStudyIdInfo': {'id': '23-003042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle Interventions Pre-Procedure', 'description': 'Subjects with paroxysmal or persistent atrial fibrillation (AF) who are scheduled to undergo elective catheter ablation of AF will participate in a 12-week multicomponent lifestyle intervention program.', 'interventionNames': ['Behavioral: Multicomponent lifestyle intervention program']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Subjects who have previously undergone catheter ablation of atrial fibrillation (AF) as part of their standard of care will have medical chart review completed to gather information.'}], 'interventions': [{'name': 'Multicomponent lifestyle intervention program', 'type': 'BEHAVIORAL', 'description': 'The multicomponent lifestyle intervention program is targeted at risk factor management, increased exercise capacity, and weight loss. The program will commence upon order/referral for ablation. Ablation would occur during the lifestyle program and the program will be continued after the ablation to complete 12 weeks or up to 36 exercise sessions.', 'armGroupLabels': ['Lifestyle Interventions Pre-Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Amanda Bonikowske', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amanda R. Bonikowske', 'investigatorAffiliation': 'Mayo Clinic'}}}}