BaroPace gets CDSCO approval for RelieveHFpEF-II clinical trial in India
BaroPace Inc., a medical technology company focused on developing pacemaker regulation techniques based on blood pressure, has been granted approval by the Central Drugs Standard Control Organisation (CDSCO) of India to carry out its clinical trial, RelieveHFpEF-II, in the country.
The RelieveHFpEF-II trial is a randomized, cross-over design, First-in-Human, Early Feasibility Study that employs BaroPace’s patent-pending real-time closed loop system, PressurePace. This technology aims to improve exercise tolerance, well-being, and blood pressure control in patients with heart failure with preserved ejection fraction (HFpEF) associated with hypertension, the most prevalent form of heart failure.
The study involves several potential firsts, including the first real-time closed loop pacemaker regulation system based on blood pressure input, real-time patient interaction capability with the closed loop to optimize treatment, and proof of safety and efficacy of real-time remote pacemaker programming. The enrolment of the first patient is anticipated in July 2023.
Michael Burnam, founder and CEO of BaroPace, commented, “The ability to regulate pacemakers in real-time based on blood pressure and the patient’s real-time, symptom-based input could usher in a new age of automated implantable cardiac device control.”
Michael Coyle, a BaroPace board member and veteran executive in the Global Cardiac Rhythm Management Industry, stated, “What is intuitively appealing about the BaroPace method of cardiac pacing is its use of the patient’s own hemodynamics to optimize pacemaker rate settings. This is very novel compared to the way pacing rates have been programmed previously.”