Clinical trial · Observational
Atrial Fibrillation Ablation and Autonomic Modulation Via Thoracoscopic Surgery, 10 Year Follow up.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrial Fibrillation | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Subgroup: GP ablation
- description
- Participants underwent thoracoscopic AF ablation with additional GP ablation as the intervention group in the AFACT study. PVI with additional left atrial ablation lines was performed and conduction block was verified. No additional intervention will be perforemd in this study. All study procedures will be the same for the two subgroups.
- label
- Subgroup: No GP ablation
- description
- Participants underwent thoracoscopic AF ablation as the control group in the AFACT study. PVI with additional left atrial ablation lines was performed and conduction block was verified. No additional intervention will be perforemd in this study. All study procedures will be the same for the two subgroups.
Primary outcomes (1)
- measure
- Freedom of AF
- timeFrame
- 10 years
- description
- Number of participants with freedom of AF after ten years after the procedure without the use of antiarrhythmic drugs. Freedom of AF is defined as the absence of documentation of episodes of AF, atrial flutter or atrial tachycardia \>30 seconds on all holters and ECG recordings during follow up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * AFACT Trial participant Exclusion Criteria: * Refusal to be contacted for future studies during or since the AFACT trial.
References
Publications (0)
Data not yet available