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

Sponsor
Michele De Bonis (Other)
Overall Status
Completed
CT.gov ID
NCT05836389
Collaborator
(none)
56
Enrollment
1
Location
15
Actual Duration (Days)
113.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pulmonary veins isoltation in bilateral thoracoscopy

Study Design

Study Type:
Observational
Actual Enrollment :
56 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Long-term Results of Bilateral Thoracoscopic Ablation for Stand-alone Atrial Fibrillation
Actual Study Start Date :
Jun 15, 2020
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2020

Outcome Measures

Primary Outcome Measures

  1. Mortality [through study completion, a minimum of 6 years]

  2. Freedom from AFib [through study completion, a minimum of 6 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 80 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Ospedale San Raffaele Milan Italy 20132

Sponsors and Collaborators

  • Michele De Bonis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michele De Bonis, Chief of Cardiac Surgery of the Advanced and Research Therapies, Ospedale San Raffaele
ClinicalTrials.gov Identifier:
NCT05836389
Other Study ID Numbers:
  • LTFUP-AFPVI
First Posted:
May 1, 2023
Last Update Posted:
May 1, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of May 1, 2023