Artificial intelligence in cardiovascular care: a systematic review and meta-analysis of randomised controlled trials

Background Artificial intelligence (AI) holds potential to transform cardiovascular care, but evidence on its effectiveness in clinical practice remains inconsistent. We aimed to synthesise evidence from randomised controlled trials (RCTs) on the effectiveness of AI-enabled cardiovascular care, summarise the trial design and characteristics of AI systems, and evaluate methodological quality and reporting transparency. Methods In this systematic review and meta-analysis, we searched Embase, MEDLINE, Scopus, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov for RCTs that evaluated effectiveness of AI interventions in cardiovascular care, published in English from database inception to July 07, 2025. The search was updated on April 28, 2026. We followed Cochrane guidance for study selection and data extraction. Risk of bias was assessed using Cochrane's Risk of Bias tools and reporting transparency using CONSORT-AI checklist. We calculated summary effects using inverse-variance-weighted random-effects meta-analyses and assessed the certainty of evidence using GRADE. Between-study heterogeneity was quantified using χ 2 (Cochran's Q) test and I 2 statistic. Publication bias was not assessed due to small number of studies. This study was registered with PROSPERO (CRD420251090250). Findings Of 12,217 records identified, 31 RCTs from 13 regions (n = 1,685,717 patients) were included in the systematic review, and 11 of these (n = 1,614,689) in the meta-analysis. Most RCTs were published after 2021 (90%), multicentre (58%), and had short follow-up duration (