Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT05040035
Status:
UNKNOWN
Last Update Posted:
2021-09-10
First Post:
2021-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ACT-Measurement at Different Location During Left Atrial Ablation Procedures
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-01', 'studyFirstSubmitDate': '2021-08-10', 'studyFirstSubmitQcDate': '2021-09-01', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of mean and median values of ACT measurements from LA und LAA and dependency on anatomic and functional LAA parameters among patients in sinus rhythm.', 'timeFrame': 'During ablation procedure', 'description': 'Active clotting time from left atrium (LA) and left atrial appendage (LAA) measured at the same time.'}], 'secondaryOutcomes': [{'measure': 'Target values of ACT measured in central venous line, LA and LAA among patients with sinus rhythm', 'timeFrame': 'During ablation procedure', 'description': 'Active clotting time from left atrium (LA) and left atrial appendage (LAA) measured with regard to target ACT over time during ablation procedure among patients with sinus rhythm.'}, {'measure': 'Target values of ACT measured in central venous line, LA and LAA among patients with atrial fibrillation', 'timeFrame': 'During ablation procedure', 'description': 'Active clotting time from left atrium (LA) and left atrial appendage (LAA) measured with regard to target ACT over time during ablation procedure among patients with atrial fibrillation.'}, {'measure': 'Dynamics of ACT values over time from samples taken from central venous line, LA and LAA among patients with sinus rhythm', 'timeFrame': 'During ablation procedure', 'description': 'Active clotting time from left atrium (LA) and left atrial appendage (LAA) measured with regard to time behaviour during ablation procedure among patients with sinus rhythm.'}, {'measure': 'Dynamics of ACT values over time from samples taken from central venous line, LA and LAA among patients with atrial fibrillation', 'timeFrame': 'During ablation procedure', 'description': 'Active clotting time from left atrium (LA) and left atrial appendage (LAA) measured with regard to time behaviour during ablation procedure among patients with atrial fibrillation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anticoagulation', 'ablation', 'atrial fibrillation', 'ACT'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Ablation of atrial fibrillation is standard therapy for symptomatic patients or patients with severely reduced systolic left ventricular ejection fraction. Complications of the procedure are ischemic thrombembolic stroke. Therefore periprocedural treatment with heparin is administered to acchieve a therapeutic anticoagulation. The efficacy of anticoagulation is measured by active-clotting time (ACT) which is measured with blood drawn mostly from the V. femoralis.\n\nDespite controlled anticoagulation periprocedural stroke is published with an incidence of up to 2% and asymptomatic cerebral embolization from 2% to 15%.\n\nThe ACT-Trial has two aims:\n\n1. Analysis of the influence of the localization of blood drawing on the measured ACT: blood from central venous line, from LA and from LAA.\n2. Dependency of the ACT measured in the blood of the LAA with regard to anatomic und functional LAA-measurements.\n\nPatients will be included scheduled for left atrial ablation procedure and will be divided in two groups: atrial fibrillation at time of procedure and sinus rhythm at time of procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with atrial fibrillation scheduled for left atrial ablation procedure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patients aged 18 until 80 years with atrial fibrillation scheduled for left atrial ablation procedure (according to 20216 ESC Guidelines for the management of atrial fibrillation" and/or "2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation" 3. signed informed consent. 4. hemoglobin \\>10 g/dl in Messungen up to 8 weeks before inclusion.\n\nExclusion criteria:\n\nIncompliance or contraindication of oral anticoagulation prior to ablation procedure.'}, 'identificationModule': {'nctId': 'NCT05040035', 'acronym': 'ACT', 'briefTitle': 'ACT-Measurement at Different Location During Left Atrial Ablation Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Internistisches Klinikum Munchen Sud'}, 'officialTitle': 'Influence of Localization of ACT-measurement and Influence of LAA on ACT Among Patients Undergoing Left Atrial Ablation Procedure.', 'orgStudyIdInfo': {'id': 'ACT_IKMS_1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ACT measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'Measurement of active clotting time (ACT)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81379', 'city': 'Munich', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Clemens Jilek, MD', 'role': 'CONTACT', 'email': 'research@jilek.de', 'phone': '+498972400'}, {'name': 'Anna Hollweg', 'role': 'CONTACT', 'phone': '+498972400'}], 'facility': 'Internistisches Klinikum München Süd', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Clemens Jilek, PD Dr', 'role': 'CONTACT', 'email': 'research@jilek.de', 'phone': '+49 89 72400', 'phoneExt': '0'}, {'name': 'Anna Hollweg', 'role': 'CONTACT', 'email': 'anna.hollweg@gmx.net', 'phone': '+49 89 72400', 'phoneExt': '4361'}], 'overallOfficials': [{'name': 'Clemens Jilek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Internistisches Klinikum Munchen Sud'}, {'name': 'Thorsten Lewalter, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Internistisches Klinikum Munchen Sud'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Internistisches Klinikum Munchen Sud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}