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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Treatment Group | No Intervention | ||
| Interventional Ablation Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVAC GOLD catheter ablation | Device | Isolation of pulmonary veins using PVAC GOLD catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of atrial fibrillation | Recurrence of atrial fibrillation during 1 year of follow-up | 1 year after ablation |
| 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 |
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Inclusion Criteria:
Indication for isolation of pulmonary veins
Age >= 65 years old
Association with the following characteristics:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mauricio I Scanavacca, MD, PhD | Arrythmia Clinical Unit Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP | São Paulo | São Paulo | 05403010 | Brazil |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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All patients in clinical treatment arm had to keep on antiarrhythmic drug for AF rhythm control strategy
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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.
| 24 hours after pulmonary vein isolation |
| Quality of Life Assessment | Quality of Life in Atrial Fibrillation Questionnaire Score | 1 year after ablation |
| D013568 |
| Pathological Conditions, Signs and Symptoms |