Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation Paroxysmal; Cardiac Arrythmias

Treatments: Device: PVAC GOLD catheter ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04023461

4471/16/137

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication for isolation of pulmonary veins

• Age >= 65 years old

• Association with the following characteristics:

  1. Symptomatic Atrial Fibrillation;
  2. Sinusal Rhythm maintenance failure for at least 1 Antiarrythmic Drugs;
  3. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Clinical Treatment Group

No Intervention group

Interventional Ablation Group

Experimental group

Treatment:

Device: PVAC GOLD catheter ablation