Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-03 @ 4:04 PM
Study NCT ID:
NCT03388333
Status:
COMPLETED
Last Update Posted:
2019-06-07
First Post:
2017-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Patients Undergoing Atrial Fibrillation 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': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood plasma.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-06', 'studyFirstSubmitDate': '2017-12-22', 'studyFirstSubmitQcDate': '2017-12-22', 'lastUpdatePostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with short term reoccurrences of atrial fibrillation after ablation.', 'timeFrame': '3 months', 'description': 'Holter ECGs and ECGs after atrial fibrillation ablation'}], 'secondaryOutcomes': [{'measure': 'Change in heart rate after pulmonary vein isolation', 'timeFrame': '3 days.', 'description': 'Heart rates are recorded at admission and release from the hospital.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'The investigators aim to find biomarkers to determine the success of pulmonary vein isolation for the treatment of atrial fibrillation.', 'detailedDescription': 'The investigators perform an observational study in patients undergoing pulmonary vein ablation to treat atrial fibrillation. Additionally, electrophysiological procedures not related to pulmonary vein isolation are also followed. The aim of the study is finding biomarkers that are able to predict short-term outcome of the procedure.The primary endpoint is defined as reoccurrences of atrial fibrillation within the first three months after pulmonary vein isolation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with atrial fibrillation schedulded for pulmonary vein isolation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with atrial fibrillation scheduled for pulmonary vein isolation with either radiofrequency of cryoballoon\n* patients scheduled for an electrophysiological study without ablation\n* patients with a catheter ablation at the cavotricuspid isthmus for the treatment of right atrial flutter\n\nExclusion Criteria:\n\n* patients with concurrent pulmonary vein isolation and ablation of the cavotricuspid isthmus\n* Acute myocardial infarction, coronary artery bypass graft surgery or open heart surgery within less than 3 months prior to inclusion'}, 'identificationModule': {'nctId': 'NCT03388333', 'briefTitle': 'Biomarkers in Patients Undergoing Atrial Fibrillation Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'A Single-center Observational Study to Find Biomarkers for the Outcome of Catheter Ablation in Patients With Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'D4/17-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atrial fibrillation ablation group', 'description': 'Patients undergoing catheter ablation for the treatment of atrial fibrillation.', 'interventionNames': ['Procedure: Catheter Ablation']}, {'label': 'Electrophysiological study group', 'description': 'Patients undergoing a diagnostic electrophysiological study without ablation.'}, {'label': 'Atrial flutter ablation group', 'description': 'Patients undergoing catheter ablation of right atrial flutter at the cavotricuspid isthmus.', 'interventionNames': ['Procedure: Catheter Ablation']}], 'interventions': [{'name': 'Catheter Ablation', 'type': 'PROCEDURE', 'armGroupLabels': ['Atrial fibrillation ablation group', 'Atrial flutter ablation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Department of Cardiology - Electrophysiology, University Heart Centre, University Hospital Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Christian Meyer, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Germany Department of Cardiology - Electrophysiology, University Heart Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Christian Meyer', 'investigatorFullName': 'Prof. Dr. Christian Meyer', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}