Sham-controlled trial finds pulmonary vein isolation no better than sham for atrial fibrillation quality of life at six months

A new randomized trial published in The Lancet found that catheter ablation using pulmonary vein isolation, or PVI, was not superior to a sham procedure for improving atrial fibrillation-related quality of life at six months. The finding comes from PVI-SHAM-AF, a double-blind, sham-controlled study — a design that is still unusual in trials of invasive heart procedures.

That makes the result notable. PVI is not a fringe treatment: It is a standard catheter-based procedure used to electrically isolate the pulmonary veins in an effort to reduce symptomatic episodes of atrial fibrillation, a common heart-rhythm disorder. It also holds a central place in current treatment guidelines for patients whose care is aimed at rhythm control. When a widely used procedure is tested against a sham intervention and does not show a quality-of-life advantage, that is clinically important, especially because symptom-based outcomes can be shaped by placebo and other contextual effects.

The trial, formally titled “Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial,” was prospective and conducted across multiple centers in Germany and Poland. Trial materials and registry information described a planned enrollment of 260 patients, randomly assigned in a 2-to-1 ratio to PVI or a sham procedure. The prespecified primary endpoint was the change at six months in atrial fibrillation-related quality of life as measured by the AFEQT summary score, a patient-reported questionnaire used in AF research. Trial materials referenced nine participating centers.

The results were scheduled for presentation Sunday at ESC Congress 2026, the annual meeting of the European Society of Cardiology, in a Hot Line 8 session. The listed presenter was Associate Professor Rolf Wachter of University Hospital Leipzig. The meeting presentation coincides with publication of the trial in The Lancet.

The finding lands against a backdrop of strong guideline support for PVI in symptomatic atrial fibrillation. The 2024 guideline from the European Society of Cardiology and the 2023 guideline from the American College of Cardiology, American Heart Association and Heart Rhythm Society both position PVI as the principal ablation strategy when rhythm control is indicated in symptomatic patients. In other words, the procedure tested in PVI-SHAM-AF is the core ablation approach already built into routine care.

The new result also stands out because sham-controlled evidence in this area has not been uniform. An earlier randomized sham-controlled trial, SHAM-PVI, published in JAMA, reported that PVI improved atrial fibrillation burden, symptoms and quality of life at six months compared with sham. The contrast does not mean ablation has been disproved, but it does underscore why blinded, sham-controlled procedure trials matter when the main outcomes are patient reported. Detailed numerical results from the Lancet paper — including effect sizes, statistical measures and safety data — were not available in the sourced material.