Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-02-25 @ 9:40 PM
Study NCT ID:
NCT03037333
Status:
UNKNOWN
Last Update Posted:
2018-10-24
First Post:
2017-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-23', 'studyFirstSubmitDate': '2017-01-18', 'studyFirstSubmitQcDate': '2017-01-27', 'lastUpdatePostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause mortality', 'timeFrame': '1 week'}, {'measure': 'infection', 'timeFrame': '1 week', 'description': 'Incidence of infection assessed by a clinical diagnosis'}, {'measure': 'hematoma > 5 cm', 'timeFrame': '1 week', 'description': 'image'}, {'measure': 'cardiac perforation', 'timeFrame': '1 week', 'description': 'Incidence of cardiac perforation assessed by a clinical diagnosis'}, {'measure': 'pneumothorax', 'timeFrame': '1 week', 'description': 'Incidence of pneumothorax assessed by a clinical diagnosis'}, {'measure': 'ventricular tachycardia', 'timeFrame': '1 week', 'description': 'Incidence of ventricular tachycardia assessed by an ECG test'}, {'measure': 'loss of capture', 'timeFrame': '1 week', 'description': 'Incidence of loss of capture assessed by an ECG test'}, {'measure': 'venous thrombosis', 'timeFrame': '1 week', 'description': 'Incidence of venous thrombosis assessed by an ultrasound'}, {'measure': 'any complication the delays definitive pacemaker > 48 hours', 'timeFrame': '1 week', 'description': 'clinical diagnosis'}], 'secondaryOutcomes': [{'measure': 'Time to start the correct cardiac stimulation with transvenous pacing', 'timeFrame': '1 week', 'description': 'minutes scale'}, {'measure': 'rates of success', 'timeFrame': '1 week', 'description': 'ECG test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['echocardiogram', 'Electrocardiogram: Electrical Alternans', 'fluoroscopy'], 'conditions': ['Bradycardia']}, 'referencesModule': {'references': [{'pmid': '26880272', 'type': 'RESULT', 'citation': 'Esmaiel A, Hassan J, Blenkhorn F, Mardigyan V. The Use of Ultrasound to Improve Axillary Vein Access and Minimize Complications during Pacemaker Implantation. Pacing Clin Electrophysiol. 2016 May;39(5):478-82. doi: 10.1111/pace.12833. Epub 2016 Mar 23.'}, {'pmid': '26539789', 'type': 'RESULT', 'citation': 'Reusz G, Csomos A. The role of ultrasound guidance for vascular access. Curr Opin Anaesthesiol. 2015 Dec;28(6):710-6. doi: 10.1097/ACO.0000000000000245.'}, {'pmid': '25829319', 'type': 'RESULT', 'citation': 'Bouaziz H, Zetlaoui PJ, Pierre S, Desruennes E, Fritsch N, Jochum D, Lapostolle F, Pirotte T, Villiers S. Guidelines on the use of ultrasound guidance for vascular access. Anaesth Crit Care Pain Med. 2015 Feb;34(1):65-9. doi: 10.1016/j.accpm.2015.01.004. Epub 2015 Mar 5.'}], 'seeAlsoLinks': [{'url': 'http://journals.sagepub.com/doi/pdf/10.1177/2048872615572598', 'label': 'Related Info'}, {'url': 'http://onlinelibrary.wiley.com/doi/10.1111/jce.12005/abstract', 'label': 'Related Info'}, {'url': 'https://cardiovascularultrasound.biomedcentral.com/articles/10.1186/s12947-015-0004-9', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A lot of questions about use of temporary transvenous pacing still remain obscure and there is no effective comparison between use of fluoroscopy versus electrocardiogram/echocardiogram in patients with bradicardias. The aim of the study is to evaluate how long does it take to start the correct cardiac stimulation with transvenous pacing in patients with bradicardias comparing use of fluoroscopy versus electrocardiogram/echocardiogram and compare rates of complications between two methods.', 'detailedDescription': 'Approximately 150 subjects will be recruited over a planned recruitment period of 18 months. Patients will be submitted to ecchocardiogram using Philips Envisor, and electrocardiogram with Philips Healthcare PageWriter TC30.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult males and females aged \\> 18 years\n* symptomatic bradicardia\n* informed consent signed.\n\nExclusion Criteria:\n\n* pregnancy\n* hemodynamic instability (pulmonary congestion / systolic arterial pressure lower than 90 mmHg)\n* body mass index greater than 40 kg/ m2\n* use of oral anticoagulation\n* acute coronary syndromes\n* left ventricle ejection fraction \\< 45%\n* presence of any kind of cardiac stimulation device'}, 'identificationModule': {'nctId': 'NCT03037333', 'acronym': 'EMERG-TV-PAC', 'briefTitle': 'Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Prospective Analysis in the EMERGEncy Between TransVenous Cardiac PACIng Guided by Fluoroscopy Versus Echocardiogram', 'orgStudyIdInfo': {'id': 'PSInCor-EMERG-TV-PAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'fluoroscopy', 'interventionNames': ['Procedure: Transvenous cardiac pacing guided by fluoroscopy']}, {'type': 'OTHER', 'label': 'ECG/ECHO', 'interventionNames': ['Procedure: Transvenous cardiac pacing guided by ECG/ECHO']}], 'interventions': [{'name': 'Transvenous cardiac pacing guided by fluoroscopy', 'type': 'PROCEDURE', 'description': 'Transvenous cardiac estimulation', 'armGroupLabels': ['fluoroscopy']}, {'name': 'Transvenous cardiac pacing guided by ECG/ECHO', 'type': 'PROCEDURE', 'description': 'Transvenous cardiac estimulation', 'armGroupLabels': ['ECG/ECHO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05.417-000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Alexandre Soeiro, MD', 'role': 'CONTACT', 'email': 'alexandre.soeiro@bol.com.br', 'phone': '5511-2661-5299'}], 'facility': 'Instituto do Coração - HMFMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Alexandre Soeiro, MD', 'role': 'CONTACT', 'email': 'alexandre.soeiro@bol.com.br', 'phone': '55-11-2661-5299', 'phoneExt': '4061'}], 'overallOfficials': [{'name': 'Alexandre Soeiro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unidade Clínica de Emergência'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}