NEW DELHI: A procedure widely used to treat atrial fibrillation (AF), an irregular heartbeat, cuts abnormal heart-rhythm episodes but may not itself be responsible for the improvement in patients’ quality of life, a new study published in The Lancet has found.The PVI-SHAM-AF trial involved 262 patients with symptomatic AF, with 173 assigned to catheter ablation and 89 to a sham procedure. Conducted between November 2021 and November 2025, the trial found that ablation, which uses a catheter to destroy tissue causing abnormal electrical signals, did not significantly improve quality of life compared with the sham procedure. The median age was 67 years.Both groups reported substantial improvement after six months. The average quality-of-life score rose from 61.3 to 81.1 in the ablation group and from 59.2 to 74.9 among those who underwent the dummy procedure. The difference was not statistically significant.The procedure did, however, clearly reduce AF. Seven-day heart monitoring detected AF in 21% of patients after ablation, compared with 41% after the dummy procedure.This distinction is important because improving quality of life is a major reason for offering AF ablation to symptomatic patients. The study therefore raises the possibility that some of the improvement patients report after the procedure may be related to expectations or reduced anxiety, rather than the ablation itself.Dr Ambuj Roy, cardiologist at AIIMS, said, “Atrial fibrillation is a common heart rhythm abnormality of the upper chambers of the heart, particularly in the elderly. It can be treated with medicines or, increasingly, by a complex procedure called catheter ablation, in which the source of the abnormal rhythm is isolated.”He said the study carried two important messages. “Many of the perceived benefits of complex procedures may be due to the placebo effect or reduction in anxiety because a procedure is performed. Thus, even established procedures need to be tested in sham trials. Second, we need to be selective in advising AF ablation, as the primary benefit of the procedure, improvement in quality of life, is now in serious doubt,” he said.
Share your thoughts in the comments
Be respectful · TOI community guidelines
Earlier AF ablation studies generally did not use a dummy procedure, so patients knew whether they had received the actual treatment, which could influence how they reported symptoms and quality of life. The new trial included patients with both paroxysmal and persistent AF, with a median age of 67 years, across nine centres in Germany and Poland.The findings do not mean ablation does not work. It reduced AF recurrence and the time patients remained in an abnormal rhythm, but did not provide a significant additional quality-of-life benefit over the dummy procedure. The researchers cautioned that the results are based on six months of follow-up, with 12-month results still awaited.
