Pulsed field ablation vs sham ablation to treat atrial fibrillation (the PFA-SHAM trial)

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00216208:11120/25:43928816 RIV/61384399:31140/25:00061510 RIV/00023884:_____/25:00010199

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

Pulsed field ablation vs sham ablation to treat atrial fibrillation (the PFA-SHAM trial)

Popis výsledku v původním jazyce

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 &lt;=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 &gt;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

Název v anglickém jazyce

Pulsed field ablation vs sham ablation to treat atrial fibrillation (the PFA-SHAM trial)

Popis výsledku anglicky

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 &lt;=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 &gt;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

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30201 - Cardiac and Cardiovascular systems

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2025

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Heart Rhythm O2

ISSN

2666-5018

e-ISSN

2666-5018

Svazek periodika

6

Číslo periodika v rámci svazku

11

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

1815-1824

Kód UT WoS článku

001629599900009

EID výsledku v databázi Scopus

2-s2.0-105015065767