An interventional study of The Vital Labs Digital Blood Pressure Monitor in Hypertension and Blood Pressure, sponsored by Riva Health. Completed at 3 sites in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by Riva Health · Not applicable, Interventional, and Other
The primary endpoints for this study are mean and standard deviation error measurements for the VLDBPM versus manual auscultation.
This is a prospective, controlled, single-arm clinical evaluation. Five hundred thirty-two (532) subjects are planned to be evaluated. Each subject's blood pressure will be measured using the VLDBPM and manual auscultation. Each subject will be observed while undergoing a series of blood pressure perturbation challenges. Means measurement differences from the test sensor and the reference auscultation measurements will be used to validate the accuracy of the VDBPM software system.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Total duration of subject participation will be 1 to 1.5 hours. Total duration of the study is expected to be 6 months.
Following medical history and patient eligibility assessments, eligible patients will be offered participation in the study. Once subjects are consented/enrolled, measurements will be performed in accordance with Data Collection Procedure section below.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 343 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →This is the only study on the registry with Riva Health as lead sponsor.
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Exclusion Criteria:
1. Pregnant and/or breastfeeding. 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
3. Are unable or unwilling to undergo all assessments associated with the study.
4. Have a history of poor quality or difficulty performing auscultation measurements.
5. Subjects shall be excluded if the Korotkoff sound [fifth phase (K5)] is not audible 6. Subjects with vascular implants in the arm of measurement, such as those used for dialysis 7. Subject suffering from a medical condition prohibiting blood flow occlusion in either arms.
8. Pre-existing conditions that may interfere with the accuracy or interpretation of auscultatory readings, such as aortic coarctation, arterial-venous malformation, occlusive arterial disease, or the presence of an antecubital bruit.
9. Subjects who have known allergies to nitroglycerin (for subjects undergoing the nitroglycerin challenge).
10. Subjects who have taken short acting nitroglycerin within 4 hours of the scheduled study. Such studies will be deferred for at least 4 hours.
11. Subjects who have taken long acting nitroglycerin within 8 hours of the scheduled study. Such studies will be deferred for at least 8 hours.
12. Subjects with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, or cardiac output is dependent upon venous return
The Vital Labs Digital Blood Pressure monitor is a software-as-a-medical device (SaMD) that is capable of determining blood pressure, after calibration, using waveform changes observed in photoplethysmogram signals. The VLDBPM captures PPG signals using the existing camera systems on iPhones. These PPG signals are normalized and processed to determine markers of blood pressure change. These markers, when transformed using a predetermined model, are capable of determining blood pressure changes from a known (calibration) set-point.
Device: The Vital Labs Digital Blood Pressure Monitor
The Vital Labs Digital Blood Pressure monitor is a software-as-a-medical device (SaMD) that is capable of determining blood pressure, after calibration, using waveform changes observed in photoplethysmogram signals.
Mean difference between BP measures
Primary efficacy
Time frame: Baseline
Standard deviation of differences between BP measures
Primary Efficacy
Time frame: Baseline
Mean difference between BP measures
Primary efficacy
Time frame: 1.5 hours
Standard deviation of differences between BP measures
Primary Efficacy
Time frame: 1.5 hours
Plan to share: No
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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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