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Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients

NCT04023461 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-07-12

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation Paroxysmal
  • Cardiac Arrythmias

Interventions

DEVICE

PVAC GOLD catheter ablation

Isolation of pulmonary veins using PVAC GOLD catheter.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Mauricio I Scanavacca, MD, PhD · Arrythmia Clinical Unit Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2021-02-20
Completion
2022-06-03

Countries

  • Brazil

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04023461 on ClinicalTrials.gov