Phase I Amount
$1,168,681
We have developed ViTrackâ¢, a cuffless, wrist-wearable device that uses a fundamentally newmethod to accurately and non-invasively measure BP continuously. ViTrack's beat-to-beat accuratemeasurements, irrespective of patient movement or wrist level to the heart, provide the patient's circadian BPpattern, including 24-hr mean BP, nighttime BP, and BP variability (BPV). In addition, ViTrack also measuresheart rate and respiratory parameters and advanced hemodynamics. The hypertensive diseases of pregnancy(HDP) are a significant cause of morbidity and mortality. The current standard for measuring BP in pregnantwomen is the periodic use of oscillometric arm-cuff devices. The oscillometric devices indirectly estimate systolic(SBP) and diastolic BPs (DBP) based on artery wall oscillations during cuff-deflation. Measurement errorsinherent to this indirect method, patient posture/movement, and wrong cuff size lead to unreliable BPmeasurements in 50% of routine office visits. Oscillometric device errors are compounded in pregnant womendue to hemodynamic and vascular changes that reduce oscillations of the arterial wall, resulting in BPunderestimation. In contrast, these hemodynamic changes will have less impact on ViTrack measurementsbecause it utilizes pressure-dependent spatiotemporal skin displacement to measure SBP and DBP directly. Inaddition, random clinic measurements during antenatal visits lead to a 30% wrong diagnosis of HDP due to whitecoat or masked hypertension. In addition, there is a need for remote and continuous accurate measurement ofBP for prediction and early deduction of preeclampsia. The 24-hour BP parameters, such as 24-hr mean SBP,nighttime BP, and BPV, are better predictors of preeclampsia than clinic BP measurements. ViTrack, the firststandalone, wearable, connected device, can provide remote, accurate circadian BP data for correct diagnosisand enable predictive monitoring for better outcomes.Our objectives in this Phase II study are: (1) to assess the accuracy of ViTrack SBP and DBP measurements inpregnant women and as well as in women with severe preeclampsia; (2) to evaluate patient tolerance (i.e.,comfort) and reliability of ViTrack's beat-to-beat 24-hr BP measurements, and assess usability; (3) to comparethe 24-hr BP profile in pregnant women with and without HDP; and (4) to compare the number ofhypotensive/hypertensive episodes with ViTrack continuous measurements vs. the current standard of care ofintermittent cuff measurements. The data generated will validate ViTrack as the first standalone wearabletechnology for accurate and continuous monitoring of BP during pregnancy.
Public Health Relevance Statement: Project Narrative
The hypertensive diseases of pregnancy are a significant cause of morbidity and mortality. ViTrack⢠is a
cuffless, wrist-wearable device that uses a fundamentally new method to accurately and non-invasively measure
blood pressure. This study will validate ViTrack as the first standalone wearable device for accurate and
continuous blood pressure monitoring during pregnancy.
Project Terms:
