Skip to main content
Clinical Trials/NCT05836389
NCT05836389
Completed
Not Applicable

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

Michele De Bonis1 site in 1 country56 target enrollmentJune 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Michele De Bonis
Enrollment
56
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 15, 2020
End Date
June 30, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Michele De Bonis

Chief of Cardiac Surgery of the Advanced and Research Therapies

Ospedale San Raffaele

Eligibility Criteria

Inclusion Criteria

  • Age between 20 and 80 years old;
  • Isolated atrial fibrillation (predominantly paroxysmal);
  • Patients undergoing ablation of atrial fibrillation (both paroxysmal and persistent) by isolation of the pulmonary veins by radiofrequency in thoracoscopy.

Exclusion Criteria

  • Age under 20 or over 80;
  • Previous trauma/deformity of the rib cage limiting the thoracoscopic approach;
  • Previous pleurisy or thoracic operations (e.g. lobectomies) conditioning the possible appearance of pleural adhesions limiting the thoracoscopic approach.

Outcomes

Primary Outcomes

Mortality

Time Frame: through study completion, a minimum of 6 years

Freedom from AFib

Time Frame: through study completion, a minimum of 6 years

Study Sites (1)

Loading locations...

Similar Trials