Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-01 @ 6:35 AM
Study NCT ID:
NCT05048004
Status:
RECRUITING
Last Update Posted:
2024-08-20
First Post:
2021-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Embolization During Pulmonary Vein Isolation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microembolic Signals (MES)', 'timeFrame': 'during the procedure', 'description': 'number of MES detected by transcranial doppler ultrasound'}], 'secondaryOutcomes': [{'measure': 'neurological outcome', 'timeFrame': 'at baseline, 0-5 days after pulmonary vein isolation', 'description': 'neurological outcome will be evaluated using the National Institute of Health Stroke Scale'}, {'measure': 'cognitive outcome', 'timeFrame': 'at baseline, 0-5 days after pulmonary vein isolation', 'description': 'cognitive outcome will be evaluated using the Montreal Cognitive Assessment'}, {'measure': 'cerebral infarctions', 'timeFrame': 'at baseline, 0-5 days after pulmonary vein isolation', 'description': 'number of new cerebral infarctions on magnetic resonance imaging'}, {'measure': 'cerebral microbleeds', 'timeFrame': 'at baseline, 0-5 days after pulmonary vein isolation', 'description': 'number of new cerebral microbleeds on magnetic resonance imaging'}, {'measure': 'cerebral macrobleeds', 'timeFrame': 'at baseline, 0-5 days after pulmonary vein isolation', 'description': 'number of new cerebral macrobleeds on magnetic resonance imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation', 'Ischemic Stroke', 'Cerebral Microembolism']}, 'descriptionModule': {'briefSummary': 'The goal of the TCD-CA study is to determine the frequency of cerebral embolization during pulmonary vein isolation using continuous transcranial Doppler examination. Different parts of the procedure, different ablation techniques and periprocedural anticoagulation regimes will be compared.', 'detailedDescription': 'Pulmonary vein isolation (PVI) is a well-established interventional treatment of patients with atrial fibrillation. Previous studies have shown that catheter-based treatments such as PVI may lead to cerebral ischemia. Cerebral ischemia related to PVI may present with new neurological deficits but may also occur as "silent brain infarction". However, even "silent brain infarctions" are associated with an increased risk of incident dementia and clinically overt new strokes. To date, it remains unclear which procedural steps of PVI are associated with an increased risk of cerebral ischemia.\n\nCerebral blood flow and microembolic signals can be detected by using transcranial doppler ultrasound (TCD). TCD has been used in clinical routine for many years and is known to be safe in stroke patients. By performing continuous TCD monitoring for microembolic signals during PVI, the aim of this study is therefore to identify, which procedural steps are associated with the occurence of cerebral microemboli. In addition, the investigators aim to compare the frequency of cerebral microemboli in different pulmonary vein isolation techniques, namely high-power with a maximum of up to 50 W (QMODE) and very high power with a maximum of up tp 90 W (QMODE +)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all patients who undergo pulmonary vein isolation as part of their treatment for atrial fibrillation at Charité-Campus Benjamin Franklin are eligible for study participation. Clinical indication for the procedure will be established by the treating physician prior to and irrespective of study participation. Patients who are unable to provide written informed consent will not be included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with atrial fibrillation undergoing first-ever catheter-based ablation at Charité-Campus Benjamin Franklin\n* age 18 years or older\n\nExclusion Criteria:\n\n* pregnancy\n* patient unable to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT05048004', 'acronym': 'TCD-CA', 'briefTitle': 'Cerebral Embolization During Pulmonary Vein Isolation', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Cerebral Embolization During Pulmonary Vein Isolation: an Observational Study', 'orgStudyIdInfo': {'id': 'EA1/215/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'QMODE intervention', 'description': 'catheter ablation performed using high-power with a maximum of up to 50 W (QMODE) and', 'interventionNames': ['Procedure: QMODE intervention']}, {'label': 'QMODE+ intervention', 'description': 'catheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +)', 'interventionNames': ['Procedure: QMODE+ intervention']}], 'interventions': [{'name': 'QMODE intervention', 'type': 'PROCEDURE', 'description': 'Patients undergoing different forms of pulmonary vein isolation are being monitored for microembolic signals (MES) by transcranial ultrasound. For standard ablation, a Thermocool Smarttouch SF (Biosense Webster) catheter will be used (50 W, target ablation index of 550).', 'armGroupLabels': ['QMODE intervention']}, {'name': 'QMODE+ intervention', 'type': 'PROCEDURE', 'description': 'Patients undergoing different forms of pulmonary vein isolation are being monitored for microembolic signals (MES) by transcranial ultrasound. For comparison, catheter ablation performed using very high power with a maximum of up tp 90 W (QMODE +) will be used.', 'armGroupLabels': ['QMODE+ intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12203', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tim B Brämswig, MD', 'role': 'CONTACT'}, {'name': 'Regina von Rennenberg, MD', 'role': 'CONTACT'}, {'name': 'Christian H Nolte, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Martin Huemer, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Philipp Attanasio, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Verena Tscholl, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tobias Schreiber, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Charité-University Medicine Berlin, Campus Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Tim B Brämswig, MD', 'role': 'CONTACT', 'email': 'tim-bastian.braemswig@charite.de', 'phone': '+4930450560624'}, {'name': 'Regina von Rennenberg, MD', 'role': 'CONTACT', 'email': 'regina-irene.freiin-von-rennenberg@charite.de', 'phone': '+493084454285'}], 'overallOfficials': [{'name': 'Christian H Nolte, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christian Nolte', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}