Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP
São Paulo, 05403010, Brazil
NCT Number: NCT04023461
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.
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Notify Me65 year and older
All sexes
Interventional
Phase 4
São Paulo, 05403010, Brazil
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.
Methods: 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Isolation of pulmonary veins using PVAC GOLD catheter.
Time frame: 1 year after ablation
Recurrence of atrial fibrillation during 1 year of follow-up
Time frame: 1 year of follow-up
Occurrence of Asymptomatic Cerebral Embolism during 1 year of follow-up
Time frame: 24 hours after pulmonary vein isolation
Esophageal Ulcer documented by Esophagus-gastro-duodenoscopy after ablation procedure
Time frame: 1 year after ablation
Quality of Life in Atrial Fibrillation Questionnaire Score
University of Sao Paulo General Hospital
Other
Acronym: PVAC
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