Status:
COMPLETED
Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients
Lead Sponsor:
University of Sao Paulo General Hospital
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation Paroxysmal
Cardiac Arrythmias
Eligibility:
All Genders
65+ years
Phase:
PHASE4
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 seg...
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 cath...
Eligibility Criteria
Inclusion
- Indication for isolation of pulmonary veins
- Age \>= 65 years old
- Association with the following characteristics:
- Symptomatic Atrial Fibrillation;
- Sinusal Rhythm maintenance failure for at least 1 Antiarrythmic Drugs;
- Diagnosis of Atrial Fibrilation on resting eletrocardiogram and/or 24h Holter.
Exclusion
- 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.
Key Trial Info
Start Date :
June 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04023461
Start Date
June 29 2017
End Date
June 3 2022
Last Update
July 12 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP
São Paulo, São Paulo, Brazil, 05403010