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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05836389
Enrollment
56
Registered
2023-05-01
Start date
2020-06-15
Completion date
2020-06-30
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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.

Interventions

PROCEDUREPulmonary veins isoltation in bilateral thoracoscopy

Ablation 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

Sponsors

Michele De Bonis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frame
Mortalitythrough study completion, a minimum of 6 years
Freedom from AFibthrough study completion, a minimum of 6 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026