PVI-SHAM-AFHot Line 8Atrial Fibrillation
Pulmonary Vein Isolation Versus Sham Procedure in Atrial Fibrillation
Pulmonary vein isolation versus sham procedure in patients with atrial fibrillation
Presenting authorRolf WachterHeart Failure / Cardiomyopathy · Leipzig UniversityRolf Wachter is Professor of Clinical and Interventional Cardiology at Leipzig University and Deputy Director of the Department of Cardiology at the University of Leipzig Medical Center. He is affiliated with the Leipzig Heart Institute and has previously been associated with institutions including the University Medical Center Göttingen. His research focuses on heart failure, atrial fibrillation, and related cardiovascular topics, with an ORCID of 0000-0003-2231-2200.
Overview
Pending sham-controlled PVI results will clarify true symptomatic benefit versus placebo in AF; provides first direct test of procedural efficacy.
Key result
Pulmonary vein isolation compared to a sham procedure in patients with atrial fibrillation is being evaluated in a late-breaking trial with results currently pending.
Discussion
Expert reaction lands here the moment PVI-SHAM-AF reports.
Expert takes
PVI-SHAM-AF is an upcoming sham-controlled trial of pulmonary vein isolation in symptomatic atrial fibrillation, led by Rolf Wachter, which completed enrollment of 262 patients and is expected to report results in late summer 2026 at ESC. It is described as the largest sham-controlled trial in AF ablation, with quality of life as its primary endpoint. It builds on the earlier SHAM-PVI trial (126 patients) that showed PVI significantly reduced AF burden compared to sham, but PVI-SHAM-AF is a distinct, larger trial. There is meaningful debate about whether sham-controlled trials are needed given existing evidence, and the trial's quality-of-life primary endpoint addresses a key gap.
Rolf Wachter
Professor of Cardiology, University of Leipzig
“Proud to announce that randomization for the PVI-sham-AF trial was successfully closed yesterday with 262 patients randomized. Primary endpoint is quality of life after 6 months. Largest sham-controlled trial in AF ablation.”
Nikolaos Dagres
Cardiologist, Deutsches Herzzentrum der Charité, Berlin
“Of course, we are not talking about surgery for cancer, or something like that. We are talking about a procedure with a mainly symptomatic endpoint where what you want to do with the procedure is in most cases reduce symptoms and improve quality of life, so subjective endpoints. Doctors and patients are not as reluctant to participate as one would have thought.”
John Mandrola
Cardiac electrophysiologist, Baptist Health Louisville
“The SHAM-PVI investigators and patients deserve our respect. Doing this experiment more than 20 years into our AF ablation experience, and in the face of great enthusiasm to increase the number of these lucrative procedures, was bold and brave. They have shown that, indeed, there is a placebo-resistant effect of PVI. But the nuances of this trial leave important questions.”
MR
Matthew Reynolds
Cardiologist, Lahey Hospital & Medical Center
“I'm not sure how that helps the field. I'm not sure if it's really worth investment of a lot of resources to go and prove that.”
Key Points
- Late-breaking clinical trial investigates the efficacy of pulmonary vein isolation compared directly with a sham procedure in patients diagnosed with atrial fibrillation.
- Catheter-based pulmonary vein isolation is tested against an invasive sham intervention to isolate the true therapeutic impact on arrhythmia recurrence and symptom burden.
- Presented at the ESC Congress late-breaking session, this controlled evaluation aims to clarify the definitive procedural benefit while clinical results remain pending.
Main Result
Absolute Event Rate: 0% vs 0%