BaroPace today announced positive outcomes from the Phase I first-in-human trial of its PressurePace pacemaker control algorithm.
PressurePace wirelessly links a pacemaker, blood pressure cuff and the algorithm to create a real-time, closed-loop therapy system.
The study met both primary endpoints of quality of life and exercise tolerance. The patent-pending algorithm for the treatment of heart failure with preserved ejection fraction (HFpEF) also met secondary endpoints of six-minute walk time and NYHA score compared to placebo.
RelieveHFpEF-II, a seven-week trial, took place at four major medical centers in India. It utilized dual-chamber pacemakers manufactured by Shree Pacetronix. After baseline assessments, 16 patients were randomized to standard pacing or PressurePace.
The average percentage of pacing for the PressurePace arm totaled 12%, BaroPace said. This suggested that inducing persistent elevation of heart rate in the patients who may also have coexisting cardiovascular disease is unnecessary. BaroPace also reported no adverse events related to its therapy.
According to a news release, investigators presented their results at last month’s HRS 2024 event in Boston. BaroPace also has a U.S. pivotal trial in the planning stage. That trial will also include pilot first-in-human feasibility studies of PressurePace in resistant hypertension.
PressurePace is a safe, very well tolerated, easy to implement personalized therapy for HFpEF, a real-time, closed-loop system that is active only when required,” said Dr. Michael Burnam, CEO and founder of BaroPace. “We are excited to begin planning RelieveHFpEF-III, the US multi-center pivotal trial of PressurePace in HFpEF patients that will study the safety and effectiveness of PressurePace in a larger number of patients over a longer period of time and to begin evaluation of PressurePace in resistant hypertension and its integration with a new cuffless blood pressure measurement device.”
