Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

Conditions
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Atrial Fibrillation Paroxysmal, Cardiac Arrythmias

Intervention / Treatment
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* Device: PVAC GOLD catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for isolation of pulmonary veins Age >= 65 years old Association with the following characteristics: Symptomatic Atrial Fibrillation; Sinusal Rhythm maintenance failure for at least 1 Antiarrythmic Drugs; Diagnosis of Atrial Fibrilation on resting eletrocardiogram and/or 24h Holter. Exclusion Criteria: Prior Atrial Fibrillation ablation; Atrial Fibrillation permanent and/or persistent; Left atrial size > 55 mm; Mechanical prothetic mitral valve replacement; Presence of atrial thrombus; Cardiac invasive procedure < 90 days; Cerebral embolism < 6 months; Hypertrophic cardiomyopathy; Contraindications to antiocoagulation and cerebral MRI.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients in clinical treatment arm had to keep on antiarrhythmic drug for AF rhythm control strategy
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Clinical Treatment Group<br> | |
| Experimental: Interventional Ablation Group<br> | Device: PVAC GOLD catheter ablation<br>* Isolation of pulmonary veins using PVAC GOLD catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial fibrillation | Recurrence of atrial fibrillation during 1 year of follow-up | 1 year after ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Asymptomatic Cerebral Embolism | Occurrence of Asymptomatic Cerebral Embolism during 1 year of follow-up | 1 year of follow-up | 
| Esophageal Ulcer | Esophageal Ulcer documented by Esophagus-gastro-duodenoscopy after ablation procedure | 24 hours after pulmonary vein isolation | 
| Quality of Life Assessment | Quality of Life in Atrial Fibrillation Questionnaire Score | 1 year after ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiofrequency Ablation, Atrial Fibrilation, PVAC GOLD catheter, Elderly patients