Michael Barbella, Managing Editor09.29.23
BaroPace Inc. has received approval from the Central Drugs Standard Control Organisation (CDSCO) of India to conduct its clinical trial RelieveHFpEF-II there.
RelieveHFpEF-II is a randomized, cross-over design, first-in-human early feasibility study using the company’s patent-pending real-time closed loop system, PressurePace, to regulate a cardiac pacemaker. PressurePace aims to improve exercise tolerance, a sense of well-being, and blood pressure control for patients with heart failure with preserved ejection fraction (HFpEF) associated with hypertension, the most common form of heart failure. RelieveHFpEF-II represents a number of potential firsts, including studying: the first real-time closed loop pacemaker regulation system based upon blood pressure input, the capability for real-time patient interaction with the closed loop to optimize treatment, and demonstration of the safety and efficacy of real-time remote pacemaker programming. First patient enrollment is expected July 2023.
“The relationship between heart rate and blood pressure has been known for 200 years but, until now, pacemakers have been blind to it and other important physiologic parameters,” BaroPace Founder/CEO Michael Burnam M.D., said. “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.”
“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,” noted BaroPace Board Member Michael Coyle, a senior executive in the global cardiac rhythm management industry.
Established in 2019, BaroPace Inc. is a clinical trial-stage medical device company developing real-time closed loop cardiac pacemaker control systems to treat drug resistant hypertension and heart failure with preserved ejection fraction. PressurePace is an investigational device and is not approved for commercial use in any geography.
RelieveHFpEF-II is a randomized, cross-over design, first-in-human early feasibility study using the company’s patent-pending real-time closed loop system, PressurePace, to regulate a cardiac pacemaker. PressurePace aims to improve exercise tolerance, a sense of well-being, and blood pressure control for patients with heart failure with preserved ejection fraction (HFpEF) associated with hypertension, the most common form of heart failure. RelieveHFpEF-II represents a number of potential firsts, including studying: the first real-time closed loop pacemaker regulation system based upon blood pressure input, the capability for real-time patient interaction with the closed loop to optimize treatment, and demonstration of the safety and efficacy of real-time remote pacemaker programming. First patient enrollment is expected July 2023.
“The relationship between heart rate and blood pressure has been known for 200 years but, until now, pacemakers have been blind to it and other important physiologic parameters,” BaroPace Founder/CEO Michael Burnam M.D., said. “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.”
“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,” noted BaroPace Board Member Michael Coyle, a senior executive in the global cardiac rhythm management industry.
Established in 2019, BaroPace Inc. is a clinical trial-stage medical device company developing real-time closed loop cardiac pacemaker control systems to treat drug resistant hypertension and heart failure with preserved ejection fraction. PressurePace is an investigational device and is not approved for commercial use in any geography.