Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-29

Study Completion Date

2022-06-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pulmonary Vein (PV) -Isolation: Arrhythmogenic Vein(s) Versus All Veins

NCT00605748

Atrial Fibrillation

UNKNOWN PHASE4

The Comparison Between the PVAM and CPVI for the Patients of PAF

NCT03026413

Atrial Fibrillation Pulmonary Vein Isolation

COMPLETED NA

Additional Low Voltage Area Ablation in Older Patients With Paroxysmal Atrial Fibrillation

NCT03462628

Paroxysmal Atrial Fibrillation

COMPLETED NA

Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drugs in Persistent Atrial Fibrillation

NCT03437356

Atrial Fibrillation

COMPLETED NA

Efficacy of Pulmonary Vein Isolation Alone in Patients With Persistent Atrial Fibrillation

NCT03514693

Atrial Fibrillation Catheter Ablation Recurrence

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Paroxysmal Cardiac Arrythmias

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All patients in clinical treatment arm had to keep on antiarrhythmic drug for AF rhythm control strategy

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

At the time of patient recruitment, they were randomly assigned to ablation or medical therapy (antiarrhythmic drug arm) according to a 1:1 stratified randomization list locked into a computer system.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clinical Treatment Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventional Ablation Group

Group Type EXPERIMENTAL

PVAC GOLD catheter ablation

Intervention Type DEVICE

Isolation of pulmonary veins using PVAC GOLD catheter.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PVAC GOLD catheter ablation

Isolation of pulmonary veins using PVAC GOLD catheter.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No