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

What was studied

This trial looked at people with AF, a type of uneven heartbeat. All of them had strong symptoms from their AF. In total, 60 people took part. Each got either pulsed field ablation or a sham. Ablation is done with a thin tube called a catheter. The sham was a fake version, so people did not know their group. Groups were set by chance. Each person had a heart monitor put in the body to track their rhythm.

What they found

After 6 months, AF came back in 2 people who had ablation. It came back in 25 people who had the sham. Quality of life scores rose by 43.9 points with ablation. They rose by 11.3 points with the sham. People in the ablation group spent less time in AF. Their scores for worry and low mood also fell more than in the sham group.

What it means for patients

The authors say ablation did better than the sham. It cut how often AF came back. It also cut the time people spent in AF. It raised quality of life as well. It also eased the worry and low mood tied to AF. The trial was set up to test if gains came only from a placebo effect.

Why it is not certain yet

The trial had only 60 people. Follow-up lasted just 6 months. All people had strong AF symptoms, so results may not hold for others. The trial was blinded on one side only. The abstract does not give details on harms or side effects. Longer and larger trials could show if these results last.

Source

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

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