BaroPace Receives Green Light for Pioneering First-in-Human Clinical Trial
Wednesday, July 26, 2023
BaroPace, a medical technology company focused on using blood pressure to regulate pacemakers for patients with heart failure with preserved ejection fraction and hypertension, has been granted approval by the Central Drugs Standard Control Organisation (CDSCO) of India to conduct its clinical trial, RelieveHFpEF-II, within the country.
The RelieveHFpEF-II trial is a randomized, cross-over design and is considered a First-in-Human, Early Feasibility Study. It will utilize BaroPace's patent-pending real-time closed loop system, PressurePace, to regulate a cardiac pacemaker. The primary objective of this trial is to improve exercise tolerance, enhance the sense of well-being, and better control blood pressure for patients who suffer from heart failure with preserved ejection fraction (HFpEF) associated with hypertension - the most common form of heart failure.
Notably, the RelieveHFpEF-II trial introduces several potential firsts in medical research. It will investigate the first real-time closed loop pacemaker regulation system based on blood pressure input. Additionally, the trial will allow real-time patient interaction with the closed loop to optimize treatment, and it aims to demonstrate the safety and efficacy of real-time remote pacemaker programming. This innovative approach seeks to address a long-standing limitation, as traditional pacemakers have not been able to consider important physiological parameters, including the relationship between heart rate and blood pressure.
BaroPace's pioneering technology holds the promise of ushering in a new era of automated implantable cardiac device control, offering the ability to regulate pacemakers in real-time based on blood pressure and real-time patient feedback.