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.
AFACT Trial participant
Refusal to be contacted for future studies during or since the AFACT trial.
The study population comprises participants from the AFACT trial, all of whom underwent thoracoscopic ablation for advanced AF. The AFACT trial encompassed 240 patients that underwent thoracosopic AF ablation for persistent AF, enlarged left atria (left atrial volume index \[LAVI\] \>33 ml/m2), prior unsuccessful catheter ablation, or patient preference for thoracoscopic ablation. Patients had a mean age at time of inclusion of 59.9 +-8.2 years and 73% of participants were male. Importantly, the surgical ablation occurred approximately 10 years ago for for all participants. During the AFACT trial, 4 out of the 240 patients died, leaving a maximum of 236 patients for this analysis.
Cohort
Prospective
Not listed
Freedom of AF
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.
Time to first AF recurrence.
Time to first AF recurrence defined as the first documentation of documentation of AF \>30 seconds during follow up.
Classification of AF recurrence
Classifications of AF recurrence and change from baseline of AF recurrence classification (paroxysmal, persistent, permanent AF, and atrial tachycardia).
Left Atrial Volume and Function
left Atrial (LA) Volume and Function 8 to 10 years post procedure compared between the two arms. And the change in Left Atrial (LA) Volume and Function from baseline to 8 to 10 years post procedure compared.
Quality of Life improvement
Improvement from baseline of functional status as measured by the RAND 36 quality of life questionnaires at 10 years
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
