Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-02-25 @ 6:35 PM
Study NCT ID:
NCT02816268
Status:
COMPLETED
Last Update Posted:
2016-06-28
First Post:
2016-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-27', 'studyFirstSubmitDate': '2016-06-24', 'studyFirstSubmitQcDate': '2016-06-27', 'lastUpdatePostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of reconnected pulmonary vein after ablation and a waíting period of 20min', 'timeFrame': '20min after procedure'}], 'secondaryOutcomes': [{'measure': 'Time to first documented recurrence of atrial fibrillation', 'timeFrame': '12 month'}, {'measure': 'Complications due to ablation', 'timeFrame': '30 days'}, {'measure': 'Number of reconnected pulmonary veins', 'timeFrame': '12 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Improving Outcome After Pulmonary Vein Isolation']}, 'descriptionModule': {'briefSummary': 'The investigators prospectively investigate the differences between contact-force guided pulmonary vein isolation (PVI) and conventional pulmonary vein isolation in patients with paroxysmal atrial fibrillation (PAF) with respect to adenosine guided unmasking of dormant conduction, procedural and clinical outcome.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (\\>=18 und \\< 80 years) with symptomatic paroxysmal AF\n* At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).\n* Oral anticoagulation with phenprocoumone, warfarine or DOAKs for at least 4 weeks prior to ablation with weekly documented INR \\> 2..\n* Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.\n\nExclusion Criteria:\n\n* Left atrial thrombus\n* Contraindications for oral anticoagulation or adenosin'}, 'identificationModule': {'nctId': 'NCT02816268', 'acronym': 'FULL CONTACT', 'briefTitle': 'Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Deutsches Herzzentrum Muenchen'}, 'officialTitle': 'Contact Force Guided Ablation Versus Conventional Pulmonary Vein Isolation for Paroxysmal Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'GER-EP-DHM-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Conventional Pulmonary vein isolation', 'description': 'Conventional pulmonary vein isolation was gained by using an irrigated tip ablation catheter', 'interventionNames': ['Other: Pulmonary vein isolation']}, {'type': 'OTHER', 'label': 'Contact force pulmonary vein isolation', 'description': 'Contact force was meassured by using the SMART-Touch ablation catheter (Biosense-Webster®)', 'interventionNames': ['Other: Pulmonary vein isolation']}], 'interventions': [{'name': 'Pulmonary vein isolation', 'type': 'OTHER', 'armGroupLabels': ['Contact force pulmonary vein isolation', 'Conventional Pulmonary vein isolation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80636', 'city': 'Munich', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deutsches Herzzentrum Muenchen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}