Pulsed field ablation vs sham ablation to treat atrial fibrillation (the PFA-SHAM trial)
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064173%3A_____%2F25%3A43928816" target="_blank" >RIV/00064173:_____/25:43928816 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11120/25:43928816 RIV/61384399:31140/25:00061510 RIV/00023884:_____/25:00010199
Result on the web
<a href="https://doi.org/10.1016/j.hroo.2025.07.103" target="_blank" >https://doi.org/10.1016/j.hroo.2025.07.103</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.hroo.2025.07.103" target="_blank" >10.1016/j.hroo.2025.07.103</a>
Alternative languages
Result language
angličtina
Original language name
Pulsed field ablation vs sham ablation to treat atrial fibrillation (the PFA-SHAM trial)
Original language description
Background: Compared with antiarrhythmic drugs, pulmonary vein isolation (PVI) reduces atrial fibrillation (AF) recurrences and AF burden. All but one previous study was unblinded, raising the possibility of a placebo effect of catheter ablation. Objective: This study aimed to compare PVI using pulsed field (PF) energy to a sham procedure in patients with symptomatic AF. Methods: PFA-SHAM is a single-blind, randomized trial of symptomatic patients with paroxysmal or persistent AF, and an Atrial Fibrillation Effect On Quality-of-Life (AFEQT) questionnaire score <=50. At enrollment, all patients receive an implantable cardiac monitor, and an electrophysiology study is scheduled 30 days later. After excluding supraventricular tachycardia as a cause of AF, patients are randomized to either sham or PVI using the pentaspline PF ablation catheter. The 2 co-primary outcomes are (1) freedom from recurrent AF, atrial tachycardia, or atrial flutter lasting >30 seconds, assessed as time to first recurrence (post 2-month blanking); and (2) change in quality of life according to the AFEQT score at 6-month post-ablation, compared between groups. Cross-over is permitted for patients with significant symptom worsening according to pre-specified rules. Key secondary outcomes include AF burden at 6 months, and differences in the Hospital Anxiety and Depression Scale, compared between groups. Results: Enrollment in the study was initiated in September 2023. As of January 2025, 50 patients have been enrolled. Results are expected by the end of 2025. Conclusion: This study compares PVI using PF energy to a sham procedure. The study will assess the effect of PVI on AF recurrences and quality of life. Trial registration number: NCT02426944
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30201 - Cardiac and Cardiovascular systems
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Heart Rhythm O2
ISSN
2666-5018
e-ISSN
2666-5018
Volume of the periodical
6
Issue of the periodical within the volume
11
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
1815-1824
UT code for WoS article
001629599900009
EID of the result in the Scopus database
2-s2.0-105015065767