Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-28 @ 11:43 AM
Study NCT ID:
NCT04023461
Status:
COMPLETED
Last Update Posted:
2022-07-12
First Post:
2019-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'At the time of patient recruitment, they were randomly assigned to ablation or medical therapy (antiarrhythmic drug arm) according to a 1:1 stratified randomization list locked into a computer system.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All patients in clinical treatment arm had to keep on antiarrhythmic drug for AF rhythm control strategy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-08', 'studyFirstSubmitDate': '2019-07-15', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of atrial fibrillation', 'timeFrame': '1 year after ablation', 'description': 'Recurrence of atrial fibrillation during 1 year of follow-up'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Asymptomatic Cerebral Embolism', 'timeFrame': '1 year of follow-up', 'description': 'Occurrence of Asymptomatic Cerebral Embolism during 1 year of follow-up'}, {'measure': 'Esophageal Ulcer', 'timeFrame': '24 hours after pulmonary vein isolation', 'description': 'Esophageal Ulcer documented by Esophagus-gastro-duodenoscopy after ablation procedure'}, {'measure': 'Quality of Life Assessment', 'timeFrame': '1 year after ablation', 'description': 'Quality of Life in Atrial Fibrillation Questionnaire Score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiofrequency Ablation', 'Atrial Fibrilation', 'PVAC GOLD catheter', 'Elderly patients'], 'conditions': ['Atrial Fibrillation Paroxysmal', 'Cardiac Arrythmias']}, 'descriptionModule': {'briefSummary': 'It is a prospective, randomized and double-blind clinical trial involving an invasive technique for isolation of pulmonary veins (PVAC gold) in relation to clinical treatment during an one year of segment. The patients included have paroxysmal atrial fibrillation (aged 65 years and older) refractory to antiarrhythmic treatments that do not have structural and / or ischemic heart diseases. This trial employed quality of life scores prior to the study and during the sixth and twelfth month of the segment, electrocardiograms and holter of 24 hours. The proposed imaging tests was the transesophageal echocardiogram before each procedure. The cerebral MRI was performed in the 24 hours post invasive procedure and Angio-tomography of the pulmonary veins in the 6-month segment.', 'detailedDescription': "Objective: Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become progressively safer and more effective with advances in single-shot devices. The aim of this study was to compare catheter ablation (CA) of second-generation pulmonary vein ablation catheter (PVAC) Gold technique versus clinical treatment in elderly patients (≥ 65 years old) with symptomatic paroxysmal AF (PAF) without structural heart diseases.\n\nMethods: Prospective randomized study that selected consecutive patients with paroxysmal atrial fibrillation older than 65 years-old in two groups: (1) PVAC ablation group and (2) antiarrhythmic drugs therapy group. Primary outcomes were AF recurrences, progression to persistent AF forms. As secondary outcomes, changes in Mini-Mental State Examination and AF Quality of Life Score were accessed.This study doesn't include payment of participants. All patients signed the informed consent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for isolation of pulmonary veins\n* Age \\>= 65 years old\n* Association with the following characteristics:\n\n 1. Symptomatic Atrial Fibrillation;\n 2. Sinusal Rhythm maintenance failure for at least 1 Antiarrythmic Drugs;\n 3. Diagnosis of Atrial Fibrilation on resting eletrocardiogram and/or 24h Holter.\n\nExclusion Criteria:\n\n* Prior Atrial Fibrillation ablation;\n* Atrial Fibrillation permanent and/or persistent;\n* Left atrial size \\> 55 mm;\n* Mechanical prothetic mitral valve replacement;\n* Presence of atrial thrombus;\n* Cardiac invasive procedure \\< 90 days;\n* Cerebral embolism \\< 6 months;\n* Hypertrophic cardiomyopathy;\n* Contraindications to antiocoagulation and cerebral MRI.'}, 'identificationModule': {'nctId': 'NCT04023461', 'acronym': 'PVAC', 'briefTitle': 'Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients', 'orgStudyIdInfo': {'id': '4471/16/137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Clinical Treatment Group'}, {'type': 'EXPERIMENTAL', 'label': 'Interventional Ablation Group', 'interventionNames': ['Device: PVAC GOLD catheter ablation']}], 'interventions': [{'name': 'PVAC GOLD catheter ablation', 'type': 'DEVICE', 'description': 'Isolation of pulmonary veins using PVAC GOLD catheter.', 'armGroupLabels': ['Interventional Ablation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Mauricio I Scanavacca, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arrythmia Clinical Unit Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Arrhythmia Clinical Unit Director', 'investigatorFullName': 'Mauricio Ibrahim Scanavacca', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}