Catheter ablation for AFib fails to improve quality of life more than a sham procedure
Catheter ablation does not significantly improve the quality of life of patients with symptomatic atrial fibrillation (AFib) more than a sham procedure involving sedation, venous access and electrical cardioversion, according to new late-breaking data presented at ESC Congress 2026. The findings were simultaneously published in The Lancet.[1]
PVI-SHAM-AF was a randomized, double-blind, sham-controlled trial included more than 250 patients with symptomatic paroxysmal or persistent AFib. Patients were randomized to undergo either catheter ablation or a sham procedure. The sham procedure was rather complex, involving sedation, venous access, time in the electrophysiology lab and even cardioversion. Each participant completed an AF Effect on the Quality of Life Questionnaire (AFEQT) at baseline and again after six months.
Overall, 173 patients were treated with catheter-based pulmonary vein isolation (PVI) ablation and another 89 patients were treated with the sham procedure. After six months, AFEQT scores improved from 61.3 to 81.1 in the catheter ablation group and from 59.2 to 74.9 in the sham procedure group. This was not viewed as a significant difference.
On the other hand, the authors noted that catheter ablation was still proven to be effective in reducing the risk of recurring episodes of AFib. Freedom from AFib after six months occurred in 73% of catheter ablation patients and 52% of sham procedure patients.
“While patients often say that their quality of life has improved after a procedure, it appears from our trial findings that most of this improvement is not attributable to the catheter ablation, but to other factors,” first author Rolf Wachter, MD, a professor with the University of Leipzig Medical Centre, said in a statement. “These could include a placebo effect, optimization of therapies or other factors. Catheter ablation delays progression of AFib but we can now use these data when we discuss what other benefits patients may expect from catheter ablation.”
One key limitation of this analysis is the more than 900 patients who chose not to participate. How might the outcome have been different if those patients had followed through?
“Willingness to accept sham allocation may have selected patients with different symptom burden, treatment expectations or preferences,” coauthor Nikolaos Dagres, MD, a professor with the German Heart Centre at Charité–University Medical Centre Berlin, explained in the same statement. “Some more severely symptomatic patients may have declined to participate because they preferred catheter ablation. Thus, selection bias may have played an important role in the outcome of this study.”
Cardiologists reflect on PVI-SHAM-AF
In a related editorial, also published in The Lancet, two cardiologists shared their own perspective on these data.[2]
Louis Segan, PhD, and Peter M. Kistler, PhD, both with The Alfred Hospital and the University of Melbourne, congratulated the authors on their study and then put a spotlight on why these findings may be surprising.
“At first glance, the findings appear paradoxical,” they wrote. “Catheter ablation successfully treated the arrhythmia, yet patients experienced no greater improvement in AFib-specific quality of life than those undergoing the sham procedure. Perhaps, however, the apparent paradox is less about the relationship between rhythm and symptoms than the nature of the comparator itself.”
The sham procedure, Segal and Kistler wrote, was much more than placebo. Each patient in the sham group still received cardioversion, known to be a legitimate treatment for AFib.
“Catheter ablation is unquestionably the most effective strategy for maintaining sinus rhythm, but cardioversion might provide meaningful symptomatic benefit while sinus rhythm persists, particularly when follow-up is limited to six months,” the two authors wrote. “The absence of a significant between-group difference in AFEQT should not necessarily be interpreted as evidence that PVI confers limited symptomatic benefit beyond sham. Although the sham group did not receive an ablation, electrical cardioversion provided effective short-term rhythm control.”
Segal and Kistler also pointed to the six-month follow-up period as a possible limitation. By not following these patients for a longer period of time, they wrote, researchers may have “limited the opportunity for differences in to emerge.”
Another key point in the editorial is that multiple studies over the years have found that catheter ablation is linked to certain benefits in quality of life. They named SHAM-PVI and PFA-SHAM as two specific examples.[3,4]
The two authors concluded on a positive note about the value of catheter ablation in certain patients presenting with AFib.
“The weight of evidence and efficacy in rhythm restoration including sham-controlled trials supports the role of catheter ablation to improve symptoms and quality of life in appropriately selected patients with AFib,” they wrote.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.