Cardiac Device Clinical Trials: Where Are the Women and What Are Their Outcomes?

This editorial commentary addressed the continued underrepresentation of women in cardiac device clinical trials — including implantable defibrillators, cardiac resynchronization therapy, and structural interventional devices — and the downstream consequences for outcomes in female patients.

The authors highlight that women enrolled in device trials at lower rates than their disease burden warrants, and that when sex-specific outcomes are analyzed, differences emerge that might influence device selection or programming. They call for regulatory requirements and research mandates to improve female enrollment and ensure sex-disaggregated outcomes reporting.

As an editorial, this piece synthesizes existing concerns rather than presenting new data. Its clinical significance lies in the advocacy message: gaps in device trial representation translate directly to uncertainty about whether published outcome benchmarks apply to women.

We rate the evidence limited. An expert editorial raising valid structural concerns about sex representation in device trials; the argument is substantiated by the existing literature it cites, but this article itself does not provide primary evidence.