Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial

Q: What did PVI-SHAM-AF show at ESC Congress 2026?

Catheter ablation for AF did not improve AF-related quality of life versus a double-blind sham procedure, despite substantially higher freedom from AF at 6 months.

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Symptomatic paroxysmal or persistent atrial fibrillation (n=262). Intervention: Catheter ablation vs. Sham procedure. Primary outcome: Between-group difference in change from baseline to 6 months in the Atrial Fibrillation Effect on the Quality-of-life Questionnaire (AFEQT) summary score (MD 2.6, 95% CI -2.7 to 8.0, p=0.36).

Rolf Wachter; Rolf Wachter; Patrick Haag (née Dilk); Tobias Uhe; Miroslav Bačák; David Petroff; Mathias Forkmann; Lars Eckardt; Thomas Gaspar; Борислав Динов; Martin Neef; Kerstin Bode; Timm Seewöster; Sotirios Nedios; Sebastian Hilbert; Matthias Lerche; Frank Lindemann; Christian Spies; Samira Beimel; Beatriz Tose Costa Paiva; Felix Hohendanner; Verena Tscholl; Radoslaw Lenarczyk; Leonard Bergau; Christian Sohns; Christiane Prettin; Ulrich Laufs; Gerhard Hindricks; Nikolaos Dagres; Rolf Wachter; Rolf Wachter; Tobias Uhe; Martin Neef; Christian Spies; Laura Ueberham; Irina Müller-Kozarez; Michael Metze; Patrick Haag (née Dilk); Kerstin Bode; Timm Seewöster; Sotirios Nedios; Sebastian Hilbert; Matthias Lerche; Angeliki Darma; Frank Lindemann; Andreas Bollmann; Florian Fahr; Ines Richter; Johannes Rotta detto Loria; Khadzhimurad Magomedov; Mateo Marin-Cuartes; Maria Buske; Niklas Lankisch; Anna Schulz; Lena Hammerich; Arash Arya; Livio Bertagnolli; Danilo Obradovic; Julia Lurz; Sergio Richter; Thomas Gaspar; Stefan Ulbrich; Micaela Ebert; Julia Mayer; Leonhard Schleußner; Mandy Flechsig; Lars Eckardt; Florian Doldi; Gerrit Frommeyer; Philipp S. Lange; Christian Ellermann; Felix Wegner; Hauke Engelke; Mathias Forkmann; Beatriz Tose Costa Paiva; S Butz; Thomas Mischke; Sonia Busch; Борислав Динов; Samuel Sossalla; Philipp Bengel; Jan Philip Huisel; Christian Fräbel; Nikita Schneider; Vincent Größer; Nikolaos Dagres; Gerhard Hindricks; Felix Hohendanner; Verena Tscholl; JIN HONG GERDS‐LI; Chong-Bin Lee; Emanuel Heil; Nora Henriette Wainstejn; Robert Hättasch; Thomas Kaas; Radoslaw Lenarczyk; Aleksandra Mikunda-Gaweł; Mateusz Pajor; Patrycja Pruszkowska-Skrzep; Zbigniew Kalarus

doi:10.1016/s0140-6736(26)01558-8

ESC 2026View all trials

PVI-SHAM-AFAtrial FibrillationThe LancetOpen Access

Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial

What happened

Catheter ablation fails to improve AF-related quality of life at 6 months versus sham.

MD +2.6
95% CI -2.7 to 8.0
P=0.36
n=262
61.3 → 81.1 vs 59.2 → 74.9 at 6 months (median 184 days); 12-month follow-up ongoing

Key points

Context & question: To determine whether catheter ablation improves atrial fibrillation-related quality of life more than a sham procedure in patients with symptomatic atrial fibrillation.
Methods & population: Double-blind, sham-controlled, multicentre randomized trial (2:1) at nine sites; 262 adults with symptomatic paroxysmal or persistent AF (median 67; 51% female); Catheter ablation (PVI) vs double-blind sham procedure; 6 months (median 184 days); 12-month follow-up ongoing follow-up.
Finding & limits: At 6 months, mean AFEQT summary score increased from 61·3 (SD 20·1) to 81·1 (16·6) in the catheter ablation group and from 59·2 (19·0) to 74·9 (19·5) in the sham group, yielding a Hodges–Lehmann between-group difference in change of 2·6 (;·36). Representation: Only 262 of 1199 invited patients consented, which may limit generalizability.

Discussion

Author’s perspective

Rolf Wachter70d ago

Hi everybody, I am the PI of PVI-SHAM-AF. Looking forward to discussing PVI-SHAM-AF with this community.

PVI-SHAM-AF co-author

Expert perspectives 19

Nassir Marrouche

Endpoint critiqueElectrophysiology

The sham arm was not ablation vs nothing. It included cardioversion, itself an effective rhythm treatment.

X post ↗

Andreas Kyriacou

Endpoint critiqueSheffield Teaching Hospitals NHS Foundation Trust

Less symptomatic patients and a mixed AF population may have left little room to show a quality-of-life gain.

X post ↗

Edgardo Alania

Practice takeHeart Failure / Cardiomyopathy · Hospital de Dénia

Ablation's effect on the rhythm is real, but part of the symptom gain after procedures may be placebo.

X post ↗

Show 16 more perspectives

C. Michael Gibson

Practice takeInterventional / Structural Cardiology · Beth Israel Deaconess Medical Center

Patient care itself contributes substantially to the benefit patients perceive after ablation.

X post ↗

Piotr Futyma

ContextElectrophysiology

Cardioversion alone may explain much of the success of recent persistent AF ablation trials.

X post ↗

Ihab Suliman

Results readoutCardiac Imaging · King Abdulaziz Cardiac Center, King Abdulaziz Medical City, National Guard Health Affairs / King Saud bin Abdulaziz University for Health Scie

Ablation reduces AF, but the symptom and QoL story is much more complicated.

X post ↗

Martha Gulati

Results readoutSt.Martha's College Of Nursing

Highlights that about half of the 262 patients were women and that QoL improved in both groups while ablation improved freedom from AF.

X post ↗

Expert perspective

Rolf Wachter76d ago

Heart Failure

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.

PVI-SHAM-AF co-author

Expert perspective

ArrhythmiaAcademy73d ago

How much of the benefit of AF ablation is physiological and how much is placebo? At #ESCCongress2026, Prof Rolf Wachter discusses findings from PVI-SHAM-AF, a sham-controlled trial designed to answer one of electrophysiology's most debated questions. 👥 262 patients 🫀

t.coPVI-SHAM-AF

Expert perspective

Brad Wilson73d ago

Does PVI improve symptoms beyond the effect of a sham procedure? Prof @RoWachter discusses the fascinating PVI-SHAM-AF results at #ESC2026 and how they compare with other sham-controlled AF ablation trials. #AFib #EPeeps #Cardioed #ESCcongress #ESC26

t.coPVI-SHAM-AF

Expert perspective

Brad Wilson73d ago

What does PVI-SHAM-AF tell us about AF ablation? Prof @RoWachter discusses the findings at #ESC2026 and the important relationship between rhythm control, AF burden and how patients actually feel. #AFib #EPeeps #Ablation #ESC26

t.coPVI-SHAM-AF

Expert perspective

Martha Gulati73d ago

General · Cedars-Sinai Medical Center

One of the #ESCCongress highlights: #HOTLINE #LBCT PVI-SHAM-AF 🫀262 patients (~1/2 women! 👏🏽)with symptomatic AF → ablation vs sham 🫀At 6 mo, AF-related QoL improved in BOTH groups, with no significant benefit from ablation (P=.36) 🫀But ablation improved freedom from AF:

t.coPVI-SHAM-AF

Expert perspective

Mohammed Al-Qadami73d ago

PVI-SHAM-AF randomized 262 patients to pulmonary vein isolation or sham. PVI was not superior for AFEQT improvement, but reduced AF recurrence by 20.1 percentage points and AF burden by 11.9 points. #PVISHAMAF #ESC2026 #AtrialFibrillation

t.coPVI-SHAM-AF

Expert perspective

John Mandrola75d ago

Electrophysiology · Baptist Health System

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.

PVI-SHAM-AF

Expert perspective

Malcolm Finlay75d ago

Electrophysiology · St Bartholomew's Hospital

We should always look to test our assumptions, and although we may believe something works, it's up to us, if we're performing high-value and complex procedures on patients, to prove that they're really worthwhile.

PVI-SHAM-AF

Expert perspective

Nikolaos Dagres75d ago

Electrophysiology · Humboldt-Universität zu 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.

PVI-SHAM-AF

Expert perspective

Matthew Reynolds75d ago

Electrophysiology · Brigham and Women's Hospital

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.

PVI-SHAM-AF

Expert perspective

Martha Gulati76d ago

General · Cedars-Sinai Medical Center

@DrDerekConnolly @DLBHATTMD @ESC_President @PZoungas @vass_vassiliou @mmartinezheart @ShelleyZieroth @robmentz @JennaSkowronski @noshreza @gabrielsteg @co_kobo @elmir1omerovic @Aspirinbk @RizosKonsta @escardio @HighSTEACS @SimoneBiscaglia @KardiologieHH @Marta33717088 @Bweber04 @RonBlankstein @purviparwani @MariamElmegaard @ankeetbhatt @kpnorcal @ratika_parkash @DalhousieU @HeartDocSharon @CMichaelGibson @BaimInstitute @mortschou @shaoliang_chen @panniyammakal @dranulala @heartofthemater @mmamas1973 @WGCPMChair @EAPCIPresident @EACVIPresident @BarbaraStahli @j_hausleiter @oyvlie @RigsHeart @HeartcentreC #HOTLINE 8 #ESCCongress #Afib 🫀PVI-SHAM-AF: Does AF ablation actually beat a SHAM procedure? Love these sham trials the most! 🫀NEXAF: Role of structured #exercise on non-permanent AF

t.coPVI-SHAM-AF

Expert perspective

Paulus Kirchhof76d ago

excellent! Looking forward to the results.

PVI-SHAM-AF

Outstanding questions

Open questions from this trial that would benefit from expert input.

Ask about this paper

Answers are grounded in this paper and cite their sources.

Full evidence

Why the trial, tables, limitations, PICO, abstract, media & sources

Why the trial?

Quality-of-life gains after AF catheter ablation had never been separated from placebo effect: no prior trial compared pulmonary vein isolation with a sham procedure under double-blind conditions.

Does catheter ablation improve atrial fibrillation-related quality of life more than a sham procedure in patients with symptomatic paroxysmal or persistent atrial fibrillation?

Evidence details

What drove the result?

Outcome	Ablation	Sham
AFEQT summary score, baseline → 6 months Primary · Hodges–Lehmann difference in change 2.6 (95% CI −2.7 to 8.0; p=0.36) — not superior to sham	Ablation 61.3 → 81.1	Sham 59.2 → 74.9
Freedom from AF at 6 months From the trial record; not reported in the publication abstract	Ablation 73%	Sham 52%

Limitations & tradeoffs

Safety: Procedure-related serious adverse events occurred in 6 vs 4 patients (including 1 ischaemic stroke in the sham group), with 1 death per arm (neither procedure-related).
Representation: Only 262 of 1199 invited patients consented, which may limit generalizability.
Statistical certainty: The confidence interval (−2.7 to 8.0) still allows a clinically relevant quality-of-life benefit.
Design limitations: Primary follow-up was 6 months (12-month follow-up ongoing), and the sham group also improved substantially (59.2 to 74.9), consistent with a strong placebo response.

Structured PICO

Does catheter ablation improve atrial fibrillation-related quality of life more than a sham procedure in patients with symptomatic paroxysmal or persistent atrial fibrillation?

Population

262 patients aged 18 years or older with symptomatic paroxysmal or persistent atrial fibrillation, followed for a median of 184 days.

Intervention

Catheter ablation

Comparator

Sham procedure

Outcome

Between-group difference in change from baseline to 6 months in the Atrial Fibrillation Effect on the Quality-of-life Questionnaire (AFEQT) summary scorepatient reported endpoint

Main Result

Mean Difference2.6 (95% CI -2.7–8)

Absolute Event Rate19.8% vs 15.7%

p-valuep=0.36

In a sham-controlled trial of patients with symptomatic atrial fibrillation, catheter ablation did not significantly improve quality of life at 6 months compared to a sham procedure.

Where experts stand

Atrial fibrillation evidence still forming

Experts read PVI-SHAM-AF as a real challenge to ablating for symptom relief: ablation kept more patients out of AF, but patients felt about as much better after a sham procedure.

Commenters accept that ablation works on the rhythm and that much of the symptom benefit after a procedure may come from context, care, and placebo. Electrophysiologists argue the sham arm was not "nothing," since it included sedation, an invasive procedure, close follow-up, and cardioversion. The open question is how much the trial's design and patient mix shaped the null quality-of-life result.

Agreement

Two electrophysiologists point to cardioversion in the sham arm as an active rhythm treatment. They argue it may explain part of the improvement seen without ablation.

2 clinicians say this directly

What they’re arguing about

supportiveneutralcautiouscritical

Counts are expert takes we classified by axis. Tap a row to see the takes behind its count.

Still unclear

Experts question whether more symptomatic patients would have shown a difference, since PVI-SHAM-AF had no AFEQT entry threshold and a roughly even mix of AF types. It is also unclear how much of the sham arm's benefit came from cardioversion and close care rather than placebo.

Implication

Ablation confers no quality-of-life benefit over sham in symptomatic AF; challenges assumptions of procedural efficacy and prompts reevaluation of indications.

Abstract

Background Guidelines recommend catheter ablation for symptom relief in patients with atrial fibrillation. The aim of this trial was to ascertain whether catheter ablation improves atrial fibrillation-related quality of life more than a sham procedure. Methods PVI-SHAM-AF was a double-blind, multicentre, randomised trial conducted at nine study sites in Germany and Poland. Patients aged 18 years or older with symptomatic paroxysmal or persistent atrial fibrillation were randomly assigned in a 2:1 ratio to catheter ablation or a sham procedure using an automated online randomisation system with variable block sizes, stratified by trial site. The primary endpoint was the between-group difference in change from baseline to 6 months in the Atrial Fibrillation Effect on the Quality-of-life Questionnaire (AFEQT) summary score. The prespecified primary analysis was done in the intention-to-treat population and included all randomly assigned patients, with missing data handled by multiple imputation. This trial is registered with ClinicalTrials.gov (NCT05119231) and 12-month follow-up is ongoing. Findings Between Nov 12, 2021, and Nov 3, 2025, 1199 patients were invited to participate in the study and 262 patients consented and were randomly assigned: 173 patients to catheter ablation and 89 to sham. The median age was 67 years (IQR 62–73); 134 (51%) were female and 128 (49%) were male. Median follow-up was 184 days (IQR 181–191). At 6 months, the mean AFEQT summary score had increased from 61·3 (SD 20·1) to 81·1 (16·6) in the catheter ablation group and from 59·2 (19·0) to 74·9 (19·5) in the sham control group. The Hodges–Lehmann estimate of the between-group difference in change was 2·6 (95% CI −2·7 to 8·0; p=0·36). One death occurred in each group; neither was considered related to the study procedure. Serious adverse events adjudicated as related or possibly related to the study procedure occurred in ten unique patients: six patients in the catheter ablation group and four patients in the sham control group. One of these was an ischaemic stroke occurred in the sham control group. Interpretation Catheter ablation did not demonstrate superiority over a sham procedure for improving atrial fibrillation-related quality of life at 6 months.

Coverage & sources

Journal, society, and media accounts. Useful signal, not independent expert judgment.

Cite This Study

Wachter et al. (2026) conducted an RCT in Symptomatic paroxysmal or persistent atrial fibrillation (n=262). Catheter ablation vs. Sham procedure was evaluated on Between-group difference in change from baseline to 6 months in the Atrial Fibrillation Effect on the Quality-of-life Questionnaire (AFEQT) summary score (MD 2.6, 95% CI -2.7 to 8.0, p=0.36). Catheter ablation did not demonstrate superiority over a sham procedure for improving atrial fibrillation-related quality of life at 6 months.

synapsesocial.com/papers/6a8fbb6517152b56e6b64833 https://doi.org/10.1016/s0140-6736(26)01558-8

Implication

Ablation confers no quality-of-life benefit over sham in symptomatic AF; challenges assumptions of procedural efficacy and prompts reevaluation of indications.

Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial

Key points