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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05836389
• Other study ID #: LTFUP-AFPVI
• Status: Completed
• Start date: June 15, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Pulmonary 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

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		through study completion, a minimum of 6 years
Primary	Freedom from AFib		through study completion, a minimum of 6 years