VL-3 Training Study

Hypertension Clinical Trial

Official title:

PROSPECTIVE STUDY EVALUATING THE VITAL LABS DIGITAL BLOOD PRESSURE MONITOR (VLDBPM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05356754
• Other study ID #: CP-0001
• Status: Completed
• Phase: N/A
• Start date: July 13, 2020
• Est. completion date: November 8, 2021

Study information

• Verified date: April 2022
• Source: Riva Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary endpoints for this study are mean and standard deviation error measurements for the VLDBPM versus manual auscultation.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male or female =18 and = 85 years of age at the Baseline Visit.

• Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

• A minimum of 30% of the data will be derived from male subjects; and a minimum of 30% of the data will be derived from female subjects.

• A minimum of 50 participants will have dark skin types, as defined by the Fitzpatrick Skin Type classification V or VI.

• Also, at least 10 participants should exhibit finger calluses, found typically on individuals who play stringed instruments frequently.

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado
United States	University of California San Francisco	San Francisco	California
United States	Diablo Clinical Research	Walnut Creek	California

Sponsors (3)

Lead Sponsor	Collaborator
Riva Health	Diablo Clinical Research, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean difference between BP measures	Primary efficacy	Baseline
Primary	Standard deviation of differences between BP measures	Primary Efficacy	Baseline
Primary	Mean difference between BP measures	Primary efficacy	1.5 hours
Primary	Standard deviation of differences between BP measures	Primary Efficacy	1.5 hours