Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-08 @ 9:38 AM
Study NCT ID:
NCT06752733
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-31
First Post:
2024-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Stunning After Electrical Cardioversion
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004554', 'term': 'Electric Countershock'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2024-12-23', 'studyFirstSubmitQcDate': '2024-12-23', 'lastUpdatePostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The recurrence of atrial arrhythmia', 'timeFrame': 'From enrollment to the end of treatment at 12 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation (AF)']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate cardiac stunning and electrocardiographic parameters through transthoracic echocardiography and 24 hours ECG conducted immediately following electrical cardioversion. The main question it aims to answer is:\n\nDo echocardiographic and electrocardiographic parameters relating to cardiac stunning predict atrial fibrillation (AF) recurrence rates after electrical cardioversion?\n\nParticipants will undergo echocardiography and a 24-hour Holter monitoring immediately after electrical cardioversion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Korea University College of Medicine, Guro Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with atrial fibrillation\n* Patients with persistent or symptomatic atrial fibrillation who are candidates for electrical cardioversion\n* Patients eligible for anticoagulation therapy for thromboembolism prevention before and after the procedure\n* Patients who can understand and provide written informed consent\n\nExclusion Criteria:\n\n* Patients under 18 years of age or over 80 years of age\n* Patients who do not consent to participate in the study\n* Patients with severe coronary artery stenosis\n* Patients with severe hepatic dysfunction\n* Patients with severe renal dysfunction\n* Patients with severe valvular heart disease\n* Patients with a high risk of severe bleeding\n* Patients with a history of atrial fibrillation-related catheter ablation or cardiac surgery\n* Patients with an expected life expectancy of less than 1 year\n* Potentially pregnant individuals\n* Patients deemed unsuitable for the study by the investigator'}, 'identificationModule': {'nctId': 'NCT06752733', 'acronym': 'AMPEA', 'briefTitle': 'Cardiac Stunning After Electrical Cardioversion', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Guro Hospital'}, 'officialTitle': 'The Association Between Myocardial Stunning and Long-term Prognosis After Electrical Cardioversion in Patients with Atrial Fibrillation', 'orgStudyIdInfo': {'id': '2020GR0213'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atrial fibrillation', 'description': 'A group of patients with atrial fibrillation refractory to pharmacological treatment who are candidates for electrical cardioversion', 'interventionNames': ['Procedure: electrical cardioversion']}], 'interventions': [{'name': 'electrical cardioversion', 'type': 'PROCEDURE', 'description': 'synchronized electrical shocks to restore normal sinus rhythm in patients with atrial fibrillation, performed under sedation', 'armGroupLabels': ['Atrial fibrillation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Medicine Guro hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Guro Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Roh Seung Young', 'investigatorAffiliation': 'Korea University Guro Hospital'}}}}