Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

Phase 4

Completed

• Conditions: Cardiac Arrythmias; Atrial Fibrillation Paroxysmal
• Interventions: Device: PVAC GOLD catheter ablation

• Registration Number: NCT04023461
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-06-29
• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2019-07-15
• Study First Posted: 2019-07-17
• Primary Completion: 2021-02-20
• Study Completion: 2022-06-03
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-08
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional Ablation Group	PVAC GOLD catheter ablation	-

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial fibrillation	1 year after ablation	Recurrence of atrial fibrillation during 1 year of follow-up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP; 🇧🇷 Sao Paulo, SP, Brazil