Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

Atrial Fibrillation Paroxysmal Clinical Trial

— PVAC  

Official title:

Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023461
• Other study ID #: 4471/16/137
• Status: Completed
• Phase: Phase 4
• Start date: June 29, 2017
• Est. completion date: June 3, 2022

Study information

• Verified date: July 2022
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 3, 2022
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrial Fibrillation Paroxysmal
• Cardiac Arrythmias

Intervention

Device:
• PVAC GOLD catheter ablation
Isolation of pulmonary veins using PVAC GOLD catheter.

Locations

Country	Name	City	State
Brazil	Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Medtronic

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of atrial fibrillation	Recurrence of atrial fibrillation during 1 year of follow-up	1 year after ablation
Secondary	Occurrence of Asymptomatic Cerebral Embolism	Occurrence of Asymptomatic Cerebral Embolism during 1 year of follow-up	1 year of follow-up
Secondary	Esophageal Ulcer	Esophageal Ulcer documented by Esophagus-gastro-duodenoscopy after ablation procedure	24 hours after pulmonary vein isolation
Secondary	Quality of Life Assessment	Quality of Life in Atrial Fibrillation Questionnaire Score	1 year after ablation