Pulsed Field Ablation Versus Sham to Treat Atrial Fibrillation: The PFA-SHAM Randomized Clinical Trial

Area of Science:

• Cardiology
• Electrophysiology
• Medical Devices

Background:

• Catheter ablation is a common treatment for atrial fibrillation (AF), but prior studies often lacked blinding, raising concerns about placebo effects.
• Pulsed field ablation (PFA) is a novel catheter ablation technology.
• This study aimed to evaluate PFA against a sham procedure in symptomatic AF patients.

Purpose of the Study:

• To compare the efficacy and safety of pulsed field ablation (PFA) versus a sham procedure for treating symptomatic atrial fibrillation (AF).
• To assess the impact of PFA on AF recurrence, quality of life, AF burden, and psychological distress.

Main Methods:

• A prospective, single-blind, randomized controlled trial involving 60 patients with highly symptomatic AF.
• Participants were randomized 1:1 to receive either PFA or a sham procedure, with continuous rhythm monitoring via implantable cardiac monitors.
• Co-primary outcomes included time to first atrial tachyarrhythmia recurrence and changes in AF-specific quality of life scores at 6 months.

Main Results:

• PFA demonstrated superior efficacy in preventing AF recurrence, with only 6.7% of patients experiencing recurrence compared to 83.3% in the sham group.
• Patients undergoing PFA showed significantly greater improvements in quality of life (Atrial Fibrillation Effect on Quality-of-Life score) and reduced AF burden.
• PFA also led to significant reductions in psychological distress, as measured by the Hospital Anxiety and Depression Scale.

Conclusions:

• Pulsed field ablation (PFA) is a highly effective treatment for symptomatic atrial fibrillation (AF), outperforming sham procedures.
• PFA significantly reduces AF recurrence, burden, and improves patient-reported outcomes, including quality of life and psychological well-being.
• These findings support the use of PFA as a superior alternative to sham procedures for AF management.