RECOVER-HF: A Sham-Controlled, Double-Blind Pivotal Trial of Synchronized Diaphragmatic Stimulation in HFrEF

Synchronized Diaphragmatic Stimulation (SDS) is a novel implantable device-based intervention designed to augment cardiac function by applying cardiac-synchronized electrical stimulation to the diaphragm without altering respiration or being perceptible to patients 1–4. The diaphragm is widely known for its central role in breathing, but it also strongly affects loading and unloading of the heart. With each breath the diaphragm acts as an ancillary cardiac pump 5. SDS harnesses the diaphragm as a natural left-ventricular assist for heart failure patients, leveraging a mechanism of action that is largely independent of cardiac anatomy, heart failure phenotypes, and patient comorbidities.