Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices

Recruiting

• Conditions: Healthy; Hypertension
• Interventions: Device: ViTrack; Device: Oscillometric BP Device; Device: Auscultatory cuff

• Registration Number: NCT04835857
• Lead Sponsor: Dynocardia, Inc

Brief Summary

(1) To compare cuff-less wrist wearable radial artery blood pressure measurements utilizing ViTrack(developed by Dynocardia) to the cuff based commercially available blood pressure device, in healthy volunteers with normal or high blood pressure.

Detailed Description

(1) The ViTrack is strapped over the radial artery at the wrist. The ViTrack blood pressure cuff will be utilized to obtain blood pressure(BP) readings in the volunteers with normal or high blood pressure. The readings from the ViTrack will be compared with the readings of a cuff-based, commercially available BP measuring device placed on the same arm.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-04-05
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Health volunteers 18 years and above; equal numbers of males and females to address Sex As a Biological Variable (SABV); and in sinus rhythm.
• Agree to commit to participate in the current protocol.
• Provide written informed consent prior to any study procedures being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).

Exclusion Criteria

• Unable or unwilling to provide informed consent
• Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator.
• A difference of >10 mm Hg in left versus right arm oscillometric systolic BP.
• Upper extremity arteriovenous hemodialysis shunt.
• Wrist distortion or pain from arthritis.
• Prior trauma or surgery at the radial artery monitoring site.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental-Arm	ViTrack	For the same subject, 1. ViTrack wrist cuff is applied on one of the wrist 2. Standard Oscillometric cuff is applied to the brachial artery / wrist of the same arm 3. Auscultatory cuff is applied to the brachial artery of the same arm
Experimental-Arm	Auscultatory cuff	For the same subject, 1. ViTrack wrist cuff is applied on one of the wrist 2. Standard Oscillometric cuff is applied to the brachial artery / wrist of the same arm 3. Auscultatory cuff is applied to the brachial artery of the same arm
Experimental-Arm	Oscillometric BP Device	For the same subject, 1. ViTrack wrist cuff is applied on one of the wrist 2. Standard Oscillometric cuff is applied to the brachial artery / wrist of the same arm 3. Auscultatory cuff is applied to the brachial artery of the same arm

Primary Outcome Measures

Name	Time	Method
Comparison of Diastolic Blood Pressure	up to 30 minutes	3 sets readings compared across blood pressure (mmHg)
Comparison of Systolic Blood Pressure	up to 30 minutes	3 sets readings compared across blood pressure (mmHg)

Secondary Outcome Measures

Name	Time	Method
Skin Irritation	Up to 72 hours	Examining for local skin irritation

Trial Locations

Locations (1)

Dynocardia Inc; 🇺🇸 Newton, Massachusetts, United States