To clarify findings from the PVI-SHAM-AF trial regarding the impact of catheter ablation on symptoms and quality of life in patients with atrial fibrillation.
Approach:
Trial Design: PVI-SHAM-AF was a multicentre, double-blind trial with sham control involving 262 participants with symptomatic paroxysmal or persistent atrial fibrillation.
Outcome Measures: The primary outcome was the change in quality of life measured by the AFEQT questionnaire over 6 months.
Key Findings:
Catheter ablation reduced atrial fibrillation recurrence (21% vs. 41% in sham) but did not show a statistically significant improvement in quality of life compared to sham treatment.
Both groups experienced clinically meaningful improvements in AFEQT scores.
The trial evaluated catheter ablation against an active sham procedure that included comprehensive clinical management.
Limitations:
The study did not assess the effects of conventional non-invasive ambulatory care on quality of life.
The observation period of 6 months may not be sufficient to capture the full effects of catheter ablation.
