Clinical trial NCT04023461: Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients
Official title: Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation Paroxysmal
Cardiac Arrythmias
Keywords: Radiofrequency Ablation
Atrial Fibrilation
PVAC GOLD catheter
Elderly patients
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2019-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients in clinical treatment arm had to keep on antiarrhythmic drug for AF rhythm control strategy
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence of atrial fibrillation
timeFrame: 1 year after ablation
Secondary outcomes:
measure: Occurrence of Asymptomatic Cerebral Embolism
timeFrame: 1 year of follow-up
measure: Esophageal Ulcer
timeFrame: 24 hours after pulmonary vein isolation
measure: Quality of Life Assessment
timeFrame: 1 year after ablation
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP
state: SP
Study officials:
affiliation: Arrythmia Clinical Unit Director
name: Mauricio I Scanavacca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: