Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT03389633
Status:
COMPLETED
Last Update Posted:
2018-01-03
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 462}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-02', 'studyFirstSubmitDate': '2017-12-20', 'studyFirstSubmitQcDate': '2018-01-02', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of recurrences of atrial fibrillation or need for new ablation', 'timeFrame': 'from 3 months after discharge until 1 year', 'description': 'idem'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients who needed to continue treatment with antiarrhythmics', 'timeFrame': 'month 3 until one year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': "Many risk factors contribute to the onset of atrial fibrillation. This study is specifically concerned with the effect of addressing these risk factors by cardiac rehabilitation on the risk of recurrence of atrial fibrillation following catheter ablation. A non-randomized, retrospective study was performed on patients treated with a catheter ablation for atrial fibrillation. The intervention group consisted of patients who chose to participate in the cardiac rehabilitation program. The control group only received standard care. The primary objective was to examine whether cardiac rehabilitation following the first ablation for atrial fibrillation resulted in a reduction of the time to or the risk of recurrence of atrial fibrillation or the need for a second ablation within 1 year after the first ablation. A Kaplan-Meier analysis was used to examine the primary objective. The secondary objectives of this study were to examine whether cardiac rehabilitation following the first ablation for atrial fibrillation had an effect on the evolution of the patients' BMI (a Mann-Whitney U test), the number of recurrences of atrial fibrillation (a Poisson regression) and the proportion of patients who need to continue treatment with antiarrhythmics 3 months following the first ablation (a chi-square test).", 'detailedDescription': 'The intervention group follows a 3 months rehab program consisting of training, education, coaching and medical follow-up. The control group are patients that chose not to follow this program. This is a retrospective non randomized trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* an ablation for AF (Atrial fibrillation)\n\nExclusion Criteria:\n\n* a complicated ablation\n* a prosthetic heart valve\n* a severe valvulopathy,\n* hyperthyroidism at the time of the ablation,\n* pregnancy and breastfeeding,\n* intensive sport (more than 1 hour a day),\n* a myocardial infarction or a thromboembolic event within 3 months after the ablation,\n* a pacemaker\n* end-stage renal disease.'}, 'identificationModule': {'nctId': 'NCT03389633', 'briefTitle': 'Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?', 'orgStudyIdInfo': {'id': '16.46/cardio16.08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rehabilitation group', 'description': 'this group follows a 3 months rehab program', 'interventionNames': ['Other: rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'No rehabilitation', 'description': 'This group does not follow a rehab program'}], 'interventions': [{'name': 'rehabilitation', 'type': 'OTHER', 'armGroupLabels': ['Rehabilitation group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Paul Dendale, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jessa Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'prof. dr. Paul Dendale', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of cardiovascular pathophysiology', 'investigatorFullName': 'prof. dr. Paul Dendale', 'investigatorAffiliation': 'Hasselt University'}}}}