Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-01 @ 10:01 AM
Study NCT ID:
NCT02516033
Status:
UNKNOWN
Last Update Posted:
2023-05-11
First Post:
2015-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hybrid Atrial Fibrillation Ablation Registry
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Full blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-10', 'studyFirstSubmitDate': '2015-08-03', 'studyFirstSubmitQcDate': '2015-08-03', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure of the hybrid ablation procedure in patients with atrial fibrillation', 'timeFrame': '1 year', 'description': 'Any (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia \\>30sec without anti-arrhythmic drugs at 1 year by ECG recording and 3-day Holter monitoring.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Hybrid Ablation', 'Efficacy', 'Risk Profile', 'Biomarkers'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '40828897', 'type': 'DERIVED', 'citation': 'Velt MJH, Magni FT, Blaauw Y, Mariani MA, Klinkenberg TJ, Rienstra M, Mulder BA. Hybrid Atrial Fibrillation Ablation: Association of Clinical Characteristics, Biomarkers, and Blanking Period with Recurrence. Interdiscip Cardiovasc Thorac Surg. 2025 Sep 1;40(9):ivaf197. doi: 10.1093/icvts/ivaf197.'}]}, 'descriptionModule': {'briefSummary': 'Recently a combined approach of surgeon ablation in combination with endocardial ablation (hybrid ablation) has been introduced. This therapy has shown excellent results in patients with previous failed endocardial ablation for paroxysmal atrial fibrillation as well in patients with persistent atrial fibrillation. The investigators hypothesize that the severity of atrial remodeling in patients with atrial fibrillation can be measured by clinical factors, echocardiographic parameters, circulating biomarkers and genetic background, and that these factors can be used to identify a risk profile to predict failure of the hybrid ablation therapy in patients with atrial fibrillation. Aim of this study is to determine a risk profile based on clinical correlates, circulating biomarkers, and genetic background associated with failure of the hybrid ablation procedure, in a prospective single center registry setting. The investigators evaluate all consecutive patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation. The investigators aim for a total of 250 participants. Extra study related procedures include blood sampling for biomarkers and genetic analysis, prolonged Holter monitoring for documentation of recurrences of atrial fibrillation/atrial flutter/atrial tachycardias, and a quality of life questionnaire. Total follow-up will be five years.\n\nMain study endpoint is failure of the hybrid ablation procedure in patients with atrial fibrillation, i.e. any (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia \\>30sec without anti-arrhythmic drugs at one year of follow-up by ECG recording and 3-day Holter monitoring.', 'detailedDescription': 'Rationale: The investigators hypothesize that the severity of atrial remodeling in patients with atrial fibrillation can be measured by clinical factors, echocardiographic parameters, circulating biomarkers and genetic background, and that these factors can be used to identify a risk profile to predict failure of the hybrid ablation therapy in patients with atrial fibrillation.\n\nObjective: To determine a risk profile based on clinical correlates, circulating biomarkers, and genetic background associated with failure of the hybrid ablation procedure in patients with atrial fibrillation.\n\nStudy design: A prospective single center registry. Study population: Patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation. The investigators aim for a total of 250 participants.\n\nIntervention: Extra study related procedures include blood sampling for biomarkers and genetic analysis at baseline and 1 year follow-up; prolonged Holter monitoring for documentation of recurrences of atrial fibrillation/ atrial flutter/atrial tachycardias at 3 months, 6 months and 1 year follow-up; and a quality of life questionnaire at baseline, and at 1 year and 5 year follow-up.\n\nTotal follow-up duration: Five years. Main study endpoints: Failure of the hybrid ablation procedure in patients with atrial fibrillation, i.e. any (a)symptomatic atrial fibrillation/atrial flutter/atrial tachycardia \\>30sec without anti-arrhythmic drugs at one year of follow-up by ECG recording and 3-day Holter monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have agreed to undergo the hybrid ablation procedure because of atrial fibrillation.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT02516033', 'briefTitle': 'Hybrid Atrial Fibrillation Ablation Registry', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Identification of a Risk Profile Associated With Failure of the Hybrid Ablation of Atrial Fibrillation.', 'orgStudyIdInfo': {'id': 'METc2014/239'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Isabelle C Van gelder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof.', 'investigatorFullName': 'I.C. Van Gelder', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}