Women in the Leadership of Interventional Structural Heart Disease Trials: A Systematic Review and Meta-Analysis.

BACKGROUND: Leadership structures in interventional structural heart disease (SHD) trials help shape trial design and conduct, yet women's representation in these roles remains poorly characterized. OBJECTIVES: The objectives of the study were to assess women's representation in trial oversight committees, leadership roles and authorship of high-impact interventional SHD trials, and to evaluate temporal trends over time. METHODS: We performed a systematic review and meta-analysis of interventional SHD trials published in high-impact journals between 2010 and 2025. For each trial, we extracted whether an oversight committee was reported and the representation of women among committee members, committee chairs, and senior authors. Pooled estimates were generated using random-effects meta-analysis, and temporal trends were assessed using generalized linear mixed-effects meta-regression. RESULTS: Among 88 eligible trials, 67.8% reported a steering committee and 55.8% provided committee member names. Among trials with available committee membership, women held 7.0% of committee seats and 56.2% of committees were composed entirely of men. Women served as committee chair in 12.0% of trials and were senior authors in 14.0% of publications. Women's representation on committees did not increase significantly over time (OR per year: 1.02; 95% CI: 0.93-1.12; P = 0.70), whereas representation of women as committee chair increased numerically but did not reach statistical significance (OR per year: 1.41; 95% CI: 1.05-2.34; P = 0.075). CONCLUSIONS: Women remain markedly under-represented in the leadership and authorship of interventional SHD trials, with no significant improvement over time. Deliberate efforts and policies to improve diversity in trial leadership may help address downstream inequities in cardiovascular evidence generation.