Clinical Trial

Atrial Fibrillation Ablation and Autonomic Modulation Via Thoracoscopic Surgery, 10 Year Follow up.

Study acronym: AFACT-10
Unknown
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Record status
This record was last updated July 12, 2024 (before its estimated August 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This observational study investigates the long-term outcomes of patients ten years after their participation in a previous study on the surgical treatment of atrial fibrillation (AF). Participants were part of a the AFACT study a decade ago that explored whether damaging nerves around the heart could reduce AF. Participants were randomized to standard thoracoscopic AF ablation (MiniMaze) with or without Ganglion Plexus (GP) ablation. This new study aims to assess and compare the long-term effects of these treatments. We are specifically interested which treatment leads to more freedom from AF. Key questions include: How many patients are free from AF ten years after treatment without using antiarrhythmic drugs? What are the complications from both treatments? Participants will undergo the following assessments: * Clinical assessment at the outpatient clinic. * ECG and 24-hour Holter ECG * Echocarddiogram and laboratory assessment. * SF-36 Quality of life questionnaire.
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06493591
Lead Sponsor Amsterdam UMC
Conditions Atrial Fibrillation
Enrollment 200 participants
Start Date 2024-09-01
Primary Completion 2025-08-01 (estimated)
Study Completion 2025-08-01 (estimated)
Updated on ClinicalTrials.gov 2024-07-12