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Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial
Rolf WachterPatrick Haag (née Dilk)Tobias UheMiroslav BačákDavid PetroffMathias ForkmannLars EckardtThomas GasparБорислав ДиновMartin NeefKerstin BodeTimm SeewösterSotirios NediosSebastian HilbertMatthias LercheFrank LindemannChristian SpiesSamira BeimelBeatriz Tose Costa PaivaFelix HohendannerVerena TschollRadoslaw LenarczykLeonard BergauChristian SohnsChristiane PrettinUlrich LaufsGerhard HindricksNikolaos DagresTobias UheMartin NeefChristian SpiesLaura UeberhamIrina Müller-KozarezMichael MetzePatrick Haag (née Dilk)Kerstin BodeTimm SeewösterSotirios NediosSebastian HilbertMatthias LercheAngeliki DarmaFrank LindemannAndreas BollmannFlorian FahrInes RichterJohannes Rotta detto LoriaKhadzhimurad MagomedovMateo Marin-CuartesMaria BuskeNiklas LankischAnna SchulzLena HammerichArash AryaLivio BertagnolliDanilo ObradovicJulia LurzSergio RichterThomas GasparStefan UlbrichMicaela EbertJulia MayerLeonhard SchleußnerMandy FlechsigLars EckardtFlorian DoldiGerrit FrommeyerPhilipp S. LangeChristian EllermannFelix WegnerHauke EngelkeMathias ForkmannBeatriz Tose Costa PaivaS ButzThomas MischkeSonia BuschБорислав ДиновSamuel SossallaPhilipp BengelJan Philip HuiselChristian FräbelNikita SchneiderVincent GrößerNikolaos DagresGerhard HindricksFelix HohendannerVerena TschollJIN HONG GERDS‐LIChong-Bin LeeEmanuel HeilNora Henriette WainstejnRobert HättaschThomas KaasRadoslaw LenarczykAleksandra Mikunda-GawełMateusz PajorPatrycja Pruszkowska-SkrzepZbigniew Kalarus
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Key result
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
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?
Key Points
- To determine whether catheter ablation improves atrial fibrillation-related quality of life more than a sham procedure in patients with symptomatic atrial fibrillation.
- In this double-blind, multicentre trial across nine sites in Germany and Poland (NCT05119231), 262 patients aged 18 years or older with symptomatic paroxysmal or persistent atrial fibrillation were randomly assigned 2:1 to catheter ablation (n=173) or a sham procedure (n=89).
- 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, evaluated in the intention-to-treat population with multiple imputation.
- At 6 months, mean AFEQT summary scores increased from 61·3 (SD 20·1) to 81·1 (16·6) with catheter ablation and from 59·2 (19·0) to 74·9 (19·5) with sham.
- The Hodges–Lehmann estimate of the between-group difference in change was 2·6 (95% CI −2·7 to 8·0; p=0·36), demonstrating no superiority of catheter ablation over the sham procedure.
- Serious adverse events related or possibly related to the study procedure occurred in six patients in the catheter ablation group and four patients in the sham group, including one ischaemic stroke in the sham group.
Evidence details
What drove the result?
| Outcome | Ablation | Sham |
|---|---|---|
| AFEQT summary score, baseline → 6 months | 61.3 → 81.1 | 59.2 → 74.9 |
| Primary · Hodges–Lehmann difference in change 2.6 (95% CI −2.7 to 8.0; p=0.36) — not superior to sham | ||
| Freedom from AF at 6 months | 73% | 52% |
| From the trial record; not reported in the publication abstract | ||
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?
P
Population
262 patients aged 18 years or older with symptomatic paroxysmal or persistent atrial fibrillation, followed for a median of 184 days.
I
Intervention
Catheter ablation
C
Comparator
Sham procedure
O
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
Main Result
Mean Difference: 2.6 (95% CI -2.7–8)
Absolute Event Rate: 19.8% vs 15.7%
p-value: p=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.
Discussion
Key questions
From the author
Rolf Wachter48d 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-authorNo takes yet. Share an insight, caveat, or question.
Where experts stand
Experts broadly accept that ablation controls AF rhythm but are struck by how much of the quality-of-life gain appears to come from the procedure experience itself, raising hard questions about what ablation truly adds for symptom relief.
The trial showed ablation clearly reduced AF recurrence compared with sham, yet quality-of-life scores improved nearly as much in the sham group. Most commenting clinicians see this as evidence that placebo and care effects play a larger role in symptom relief than previously assumed. The live question is whether this result should change how clinicians counsel patients or whether design choices like baseline symptom thresholds and the active sham protocol explain the narrowed gap.
Agreement
Multiple clinicians agree that ablation genuinely reduces AF but that the symptomatic and quality-of-life benefit may be substantially inflated by contextual or placebo effects.
3 clinicians say this directly
Main debate
Was the sham arm too active, or does this trial expose a genuine placebo effect of ablation?
Sham arm was itself therapeutic3
The sham procedure included sedation, cath-lab exposure, cardioversion, and intensive follow-up, all of which could independently improve symptoms.vs
Result reflects real placebo effect1
The trial shows that rhythm efficacy is real but much of the symptomatic gain after ablation is contextual.+5Not placed10 reporting, watching, or context only
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
It remains unclear whether selecting more symptomatic patients (as PFA-SHAM did with stricter AFEQT thresholds) would have produced a significant quality-of-life difference. Experts also question whether cardioversion offered in the sham arm constitutes rhythm control that blurs the comparison. How guidelines should incorporate this finding alongside other sham-controlled AF ablation trials is an open question.
Key expert perspectives
RWRolf WachterProfessor of Cardiology, University of LeipzigContextBefore results
The largest sham-controlled trial in AF ablation completed enrollment with 262 patients
Wachter, the trial's lead investigator, announced that PVI-SHAM-AF completed enrollment of 262 patients, making it the largest sham-controlled trial in AF ablation with quality of life as the primary endpoint.
Distilled from their postOriginal post
The sham arm was not 'nothing' and included sedation, cath-lab time, follow-up, and cardioversion
Marrouche emphasizes that interpreting PVI-SHAM-AF requires understanding what the sham arm actually delivered. Patients randomized to sham received deep sedation, an invasive cath-lab procedure, intensive follow-up, and cardioversion when they were in AF, making the control arm itself an effective form of rhythm control.
Distilled from their postX post
Higher baseline AFEQT and a different AF-type mix left less room to detect a quality-of-life difference
Kyriacou points out that PVI-SHAM-AF had no minimum symptom-severity threshold and a baseline AFEQT around 60, leaving less room to improve compared with PFA-SHAM, which required AFEQT of 50 or below. He also notes the trials enrolled very different mixes of paroxysmal and persistent AF, which may produce different placebo-response profiles.
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. Funding Helios Gesundheit (Förderung Leipziger Herzmedizin).
The Lancet · ESC 2026. Ablation's quality-of-life benefit in symptomatic AF no better than sham. PVI-SHAM-AF: Catheter ablation for symptomatic atrial fibrillation (PVI-SHAM-AF): a randomised, double-blind, sham-controlled, multicentre trial 262 patients: Symptomatic paroxysmal or persistent AF, Germany and Poland. Double-blind, sham-controlled trial: Catheter ablation vs Sham procedure. 2.6 AFEQT score difference. Quality of life not superior to sham, p=0.36. Freedom from AF at 6 months: Ablation 73% vs Sham 52%. Bottom line: Ablation gave no quality-of-life benefit over sham; indications need reevaluation.
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 (difference 2.6, p=0.36).
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