Clinical Trials Logo
  1. Home
  2. Atrial Fibrillation Paroxysmal
  3. NCT04023461

Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients — PVAC  

Atrial Fibrillation Paroxysmal Clinical Trial

Official title:
Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04023461
Study type Interventional
Source University of Sao Paulo General Hospital
Contact
Status Completed
Phase Phase 4
Start date June 29, 2017
Completion date June 3, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06085014 - Clinical and Electrophysiological Predictors of Arrhythmic Recurrence in Patients With Paroxysmal AF Undergoing First Ablation Procedure of AF by Pulmonary Vein Isolation
Recruiting NCT03724383 - Atrial Fibrillation Lifestyle Project N/A
Active, not recruiting NCT04544397 - Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation
Not yet recruiting NCT05940597 - Pulsed Field Ablation vs Cryoablation In Paroxysmal Atrial Fibrillation N/A
Not yet recruiting NCT04447300 - Outcomes of High Power Application in Catheter Ablation of Paroxysmal Atrial Fibrillation Guided by Unipolar Signal Modification. N/A
Recruiting NCT05251545 - Randomized Trial: High Power Short Duration Versus Ablation Index N/A
Recruiting NCT05883631 - RESOLVE-AF: Clinical Evaluation of the Ablacathâ„¢ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-PV Sources of Atrial Fibrillation and Guide Ablation Therapy. N/A
Not yet recruiting NCT04600713 - Physiotherapist-led Exercise Within Cardiac Rehabilitation and Paroxysmal Atrial Fibrillation and COVID-19. N/A
Enrolling by invitation NCT05725187 - Prospective Validation Study of AI-based Prediction Algorithm for the Prediction of Paroxysmal Atrial Fibrillation
Recruiting NCT04606693 - Value of Screening and Treatment of SAHS in the Management of AF Ablation Candidates N/A
Recruiting NCT05328882 - Early Recurrences of Atrial Arrhythmias and Their Impact on Late Recurrence After Pulmonary Vein Isolation With Pulsed Field Ablation of Paroxysmal Atrial Fibrillation
Recruiting NCT04342312 - Intensive Molecular and Electropathological Characterization of Patients Undergoing Atrial Fibrillation Ablation
Recruiting NCT05549752 - Flecainide Versus Amiodarone in the Cardioversion of Paroxysmal Atrial Fibrillation at the Emergency Department, in Patients With Coronary Artery Disease Without Residual Ischemia Phase 3
Completed NCT03323099 - Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation N/A
Completed NCT05461859 - Cardioneuroablation for the Treatment of Vagally-mediated Atrial Fibrillation.
Enrolling by invitation NCT04634461 - The Relationship Between Panic Attack Symptoms and Atrial Fibrillation Episodes.
Recruiting NCT06392932 - Esophageal Temperature During PVI Using Q-DOT Micro N/A
Not yet recruiting NCT06364215 - Posterior Wall Substrate Modification Using Irreversible Electroporation for Paroxysmal Atrial Fibrillation N/A
Recruiting NCT05292209 - RiLuzole to Reduce Atrial FIb Study Using Holter Monitoring Phase 2
Completed NCT04511520 - Efficacy of Personalized Exercise Program and Trimetazidine in Rehabilitation of Patients After RFA of AF N/A