Clinical Trials Directory

Trials / Completed

CompletedNCT05836389

Long-term Results of Bilateral Thoracoscopic Ablation for Stand-alone Atrial Fibrillation

Status
Completed
Phase
Study type
Observational
Enrollment
56 (actual)
Sponsor
Michele De Bonis · Academic / Other
Sex
All
Age
20 Years – 80 Years
Healthy volunteers

Summary

Atrial fibrillation (AFib) represents the most frequent cardiac arrhythmia whose prevalence appears to be increasing in the general population. Furthermore, this arrhythmia determines an increased risk of neurological complications (stroke) and, consequently, of mortality and morbidity. Currently, the first choice for the treatment of AFib is represented by the use of antiarrhythmic drugs. In patients who do not respond to pharmacological treatment, the ESC 2016 European guidelines recommend the execution of transcatheter ablation (Class I, level of evidence A). However, minimally invasive pulmonary vein isolation surgery (PVI) is recommended for subjects who are not even responsive to transcatheter ablation (Class IIa, Level of Evidence B). Previous studies have demonstrated good short-term results of thoracoscopic AFib ablation using PVI, with a 1-year freedom from atrial fibrillation recurrence without antiarrhythmic drugs of approximately 64-73%. However, only a few authors have described the medium-long term follow-up outcomes. The aim of this study is to report the long-term follow-up data of ablation of isolated, predominantly paroxysmal atrial fibrillation performed by isolation of the pulmonary veins by radiofrequency in bilateral thoracoscopy.

Conditions

Interventions

TypeNameDescription
PROCEDUREPulmonary veins isoltation in bilateral thoracoscopyAblation of the atrial fibrillation performin isolation of the pulmonary vein. The procedure is video-assisted, access is minimally invasive: access to the heart is provided to instruments and camera via small bilateral chest incisions

Timeline

Start date
2020-06-15
Primary completion
2020-06-30
Completion
2020-06-30
First posted
2023-05-01
Last updated
2023-05-01

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05836389. Inclusion in this directory is not an endorsement.