Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT04919902
Status:
UNKNOWN
Last Update Posted:
2021-06-11
First Post:
2021-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prague Registry of Electric Cardioversion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001282', 'term': 'Atrial Flutter'}], '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': 5000}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-09', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute major complications', 'timeFrame': 'Within 24 hours from the procedure', 'description': 'Major thromboembolic events or events related to cardioversion requiring unplanned hospitalisation (bleeding, severe bradycardia, anesthesia-related complications, heart failure etc)'}, {'measure': 'Subacute major complications', 'timeFrame': '24 hours to 30 days after the procedure', 'description': 'Major thromboembolic events or events related to cardioversion requiring unplanned hospitalisation (bleeding, severe bradycardia, anesthesia-related complications, acute heart failure etc), evaluated by structured phone call.'}], 'secondaryOutcomes': [{'measure': 'Acute minor complications', 'timeFrame': 'Within 24 hours from the procedure', 'description': 'Minor procedure-related complications not requiring acute hospitalisation (asymptomatic bradycardia, post-anesthesia spasms)'}, {'measure': 'Acute efficacy', 'timeFrame': 'Within 2 hours from the procedure', 'description': 'Presence of sinus rhythm on continous ECG (5-lead) monitoring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anticoagulants', 'Anticoagulation', 'Cardioversion', 'NOAC', 'DOAC'], 'conditions': ['Atrial Fibrillation', 'Atrial Flutter', 'Atrial Arrhythmia', 'Atrial Tachycardia']}, 'descriptionModule': {'briefSummary': 'This single-center observational registry follows contemporary efficacy and short-term complications of elective electric cardioversion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hemodynamically stable patients scheduled for ambulatory electric cardioversion for atrial arrhythmias based on established clinical indications.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive out-patients undergoing electric cardioversion for atrial fibrillation, atrial tachycardia, or typical atrial flutter\n\nExclusion Criteria:\n\n* Unstable patients with acute conditions requiring unplanned hospitalization'}, 'identificationModule': {'nctId': 'NCT04919902', 'acronym': 'PRAGUE-ECV', 'briefTitle': 'Prague Registry of Electric Cardioversion', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute for Clinical and Experimental Medicine'}, 'officialTitle': 'Prague Registry of Electric Cardioversion for Supraventricular Arrhythmias', 'orgStudyIdInfo': {'id': 'EKV2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Electric cardioversion', 'description': 'Patients who underwent elective cardioversion for atrial arrhythmia', 'interventionNames': ['Procedure: Electric cardioversion']}], 'interventions': [{'name': 'Electric cardioversion', 'type': 'PROCEDURE', 'description': 'Electric cardioversion in short sedation according to established clinical practice and indications', 'armGroupLabels': ['Electric cardioversion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14059', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Marek Sramko, MD, PhD', 'role': 'CONTACT', 'email': 'marek.sramko@ikem.cz', 'phone': '+420731682681'}], 'facility': 'Institute for Clinical and Experimental Medicine (IKEM)', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Clinical and Experimental Medicine', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department of Acute Cardiology', 'investigatorFullName': 'Marek Sramko', 'investigatorAffiliation': 'Institute for Clinical and Experimental Medicine'}}}}