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NCT Number: NCT04023461

Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

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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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP

São Paulo, 05403010, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PVAC GOLD catheter ablation

Device

Isolation of pulmonary veins using PVAC GOLD catheter.

Primary outcomes

  1. Recurrence of atrial fibrillation

    Time frame: 1 year after ablation

    Recurrence of atrial fibrillation during 1 year of follow-up

Secondary outcomes

  1. Occurrence of Asymptomatic Cerebral Embolism

    Time frame: 1 year of follow-up

    Occurrence of Asymptomatic Cerebral Embolism during 1 year of follow-up

  2. Esophageal Ulcer

    Time frame: 24 hours after pulmonary vein isolation

    Esophageal Ulcer documented by Esophagus-gastro-duodenoscopy after ablation procedure

  3. Quality of Life Assessment

    Time frame: 1 year after ablation

    Quality of Life in Atrial Fibrillation Questionnaire Score

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Medtronic

Registry information

Acronym: PVAC

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Jul 17, 2019
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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