Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-27 @ 4:08 PM
Study NCT ID:
NCT02306460
Status:
TERMINATED
Last Update Posted:
2024-04-10
First Post:
2014-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frontal Cognitive Control Functions Before and After Percutaneous Catheter Procedures in Treatment of Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Changes in personnel', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2014-07-11', 'studyFirstSubmitQcDate': '2014-11-30', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in response speeds (ms) and response error rate (%) in the executive RT-test', 'timeFrame': '1 day before procedure, 3 months and 1 year after post-procedure'}], 'secondaryOutcomes': [{'measure': 'Changes in amplitude of N2/P3 complex in the EEG recording', 'timeFrame': '1 day before procedure, 3 months and 1 year after post-procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neurobehavioral Manifestations', 'POCD', 'Atrial Fibrillation', 'Anti-Arrhythmia', 'Atrial Appendage Closure'], 'conditions': ['Neurobehavioral Manifestations', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation is a common arrythmia. It is an independent risk factor for stroke. There for anticoagulation therapy is used for atrial fibrillation patients. Alternatively, left atrial appendix closure can be used, if the risk for bleeding complications is deemed greater than the possible antithrombotic benefit of anticoagulation medication. Up to 70% of ischemic complications can be prevented with anticoagulation therapy, and left atrial appendix closure seems to have comparable results. Also left atrial catherter ablation (LACA) is gaining popularity as a therapeutic intervention for atrial fibrillation.\n\nHowever, the procedure is associated with 0,5-1% perioperative risk of clinically evident transient ischemic attack (TIA) or stroke. While the incidence of clinically evident ischemic complications remain relatively low, recent data suggest that 13%-20% of patients undergoing LACA are affected by post-operative neurocognitive dysfunction (POCD) 90 days after ablation.\n\nThe goal of the study is to improve detection of subtle brain dysfunction after cardiac interventions by employing an experimental executive reaction time (RT) test along with EEG recording in aims to improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone atrial fibrillation ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 80 patients will be drafted for the study. The subjects will be recruited from Tampere University Hospital Heart Hospital Co. Total of fifty patients, men and women between 50-70 years, undergoing left atrial catheter ablation (LACA) (30 patients) or percutaneous left atrial appendix closure procedure (20 patients) because of paroxysmal or persistent atrial fibrillation, will be recruited for the study.\n\nA control group of 15 patients with paroxysmal atrial fibrillation and 15 patients with persistent atrial fibrillation who are treated with antiarrhythmic and anticoagulation therapies suggested by current guidelines will be tested with the same testing schema and time points. Control group will be drafted from the cardiologic patients of the Heart Hospital and also from Hatanpää Hospital cardiologic outpatient clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 50-70\n* undergoing left atrial catheter ablation or percutaneous left atrial appendix closure procedure\n* In the ablation group, patients will qualify for the study if they have symptomatic atrial fibrillation (EHRA classification 2-4) and if their risk of thromboembolic complications with CHA2DS2VASc scale is low (0-2 points).\n\nExclusion Criteria:\n\n* Age under 18 or over 70 years.\n* Contraindication for anticoagulation therapy (in ablation group),\n* Previous neurological or psychiatric disorder.\n* Significant visual problem that can't be corrected for,\n* problems with upper arm/hand use, that would make the execution of the test difficult.\n* normal contraindications for the ablation and appendix closure procedures."}, 'identificationModule': {'nctId': 'NCT02306460', 'briefTitle': 'Frontal Cognitive Control Functions Before and After Percutaneous Catheter Procedures in Treatment of Atrial Fibrillation', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Frontal Cognitive Control Functions Before and After Percutaneous Catheter Procedures in Treatment of Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'R14068'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'left atrial catheter ablation'}, {'label': 'left atrial appendix closure'}, {'label': 'paroxysmal atrial fibrillation control group'}, {'label': 'persistent atrial fibrillation control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Heart Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Kaisa Hartikainen, MD, Docent', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Behavioral Neurology Research Unit'}, {'name': 'Kati Järvelä, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tampere Heart Hospital'}, {'name': 'Arvi Yli-Hankala, MD, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Jonne Liimatainen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}, {'name': 'Pekka Raatikainen, MD, Docent', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tampere Heart Hospital'}, {'name': 'Jaakko Inkovaara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tampere University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Kati Järvelä', 'investigatorAffiliation': 'Tampere University Hospital'}}}}