{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T07:28:43Z","timestamp":1793258923271,"version":"4.5.0"},"reference-count":21,"publisher":"American Medical Association (AMA)","issue":"14","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2024,10,8]]},"abstract":"\n Importance<\/jats:title>\n There are concerns that pulmonary vein isolation for atrial fibrillation may have a profound placebo effect, but no double-blind randomized clinical trials have been conducted.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To determine whether pulmonary vein isolation is more effective than a sham procedure for improving outcomes in atrial fibrillation.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n Double-blind randomized clinical trial conducted at 2 tertiary centers in the UK between January 2020 and March 2024 among patients with symptomatic paroxysmal or persistent atrial fibrillation. Major exclusion criteria included long-standing persistent atrial fibrillation, prior left atrium ablation, other arrhythmias requiring ablative therapy, a left atrium of 5.5 cm or larger, and ejection fraction of less than 35%.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n Participants were randomly assigned to receive pulmonary vein isolation with cryoablation (n\u2009=\u200964) or a sham procedure with phrenic nerve pacing (n\u2009=\u200962).<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary end point was atrial fibrillation burden at 6 months, excluding a 3-month blanking period. Secondary outcomes included quality-of-life measures, time to events, and safety. Atrial fibrillation burden was measured by an implantable loop recorder.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 126 participants were randomized (mean age, 66.8 years; 89 men [70.63%]; 20.63% with paroxysmal atrial fibrillation). The absolute mean atrial fibrillation burden change from baseline to 6 months was 60.31% in the ablation group and 35.0% in the sham group (geometric mean difference, 0.25; 95% CI, 0.15-0.42;\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). The estimated difference in the overall Atrial Fibrillation Effect on Quality of Life score at 6 months, favoring catheter ablation, was 18.39 points (95% CI, 11.48-25.30 points). The Short Form 36 general health score also improved substantially more with ablation, with an estimated difference of 9.27 points at 6 months (95% CI, 3.78-14.76 points).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n Pulmonary vein isolation resulted in a statistically significant and clinically important decrease in atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life, compared with a sham procedure.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT04272762<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2024.17921","type":"journal-article","created":{"date-parts":[[2024,9,2]],"date-time":"2024-09-02T06:30:29Z","timestamp":1725258629000},"page":"1165","source":"Crossref","is-referenced-by-count":63,"title":["Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial 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