SAMMAMISH, Wash. — BaroPace Inc., a medical device company focused on the development of PressurePace™, a real-time physiologic control software and hardware to regulate cardiac pacemakers to treat resistant hypertension and heart failure with preserved ejection fraction (HFpEF), today announced that the first patient has been enrolled in the Company’s First-in-Human (FIH) clinical trial, RelieveHFpEF-II. RelieveHFpEF-II will evaluate the safety and effectiveness of PressurePace™, the Company’s proprietary real-time closed loop pacemaker control algorithm that, for the first time, regulates a cardiac pacemaker according to blood pressure in patients with HFpEF.
RelieveHFpEF-II is a multicenter, double-blind, crossover study of sixteen subjects with HFpEF caused by hypertension being conducted in India that compares standard pacemaker therapy, including rate adaptive pacing via pacemaker accelerometer, with PressurePace™. After one week of baseline measurements, patients maintaining stable blood pressure and body weight are randomized to three weeks of standard pacemaker therapy versus PressurePace™ (“BaroPacing”). Pacemaker programming adjustments are made twice daily at the patient’s home in the treatment group (BaroPacing) with sham programming performed in the standard treatment (placebo) group. Primary endpoints of the trial are safety, improved exercise performance (modified BRUCE treadmill protocol and six-minute walk test), and the Minnesota Living with Heart Failure Questionnaire. Secondary endpoints include blood pressure control (systolic and diastolic blood pressure and 24-hour blood pressure monitoring), atrial fibrillation incidences, and hospitalization frequency.
“We’re pleased to initiate this First-in-Human trial of PressurePace™,” said Michael Burnam MD, BaroPace’s Co-founder and CEO. “This milestone highlights our commitment to developing new, innovative non-pharmacologic technology that improves the quality of life and longevity of patients worldwide with resistant hypertension and HFpEF, two of the most important unmet needs in cardiovascular medicine. We look forward to continued enrollment of subjects in RelieveHFpEF-II.”
