Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients (PVAC)

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrythmias; Atrial Fibrillation Paroxysmal
• Intervention / Treatment: Device: PVAC GOLD catheter ablation

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403010
      • Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Clinical Treatment Group
Experimental: Interventional Ablation Group	Device: PVAC GOLD catheter ablation; Isolation of pulmonary veins using PVAC GOLD catheter.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Medtronic
• Investigators: Principal Investigator: Mauricio I Scanavacca, MD, PhD, Arrythmia Clinical Unit Director

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2017
• Primary Completion (Actual): February 20, 2021
• Study Completion (Actual): June 3, 2022

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: July 15, 2019
• First Posted (Actual): July 17, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Elderly patients; Radiofrequency Ablation; Atrial Fibrilation; PVAC GOLD catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 4471/16/137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No