Recruiting

Cuff-Less vs. Cuff Based

Sponsor:

Dynocardia, Inc

Code:

NCT04835857

Conditions

Hypertension

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ViTrack

Oscillometric BP Device

Auscultatory cuff

Study Details

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.

Conditions

Hypertension

Healthy

Study ID

NCT04835857

Start date

Jan 1, 2021

Status verified date

Aug, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

91 participants

Anticipated

Interventions and Outcome Measures

Arms

Experimental-Arm

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

Interventions

ViTrack

ViTrack is a continuous non-invasive wearable blood pressure cuff.

Oscillometric BP Device

Oscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings.

Auscultatory cuff

The auscultatory method is the gold standard for clinical blood pressure measurement. A brachial cuff is mounted and a trained healthcare provider uses a sphygmomanometer and listens for the Korotkoff sounds using a stethoscope to measure blood pressure.

Primary outcome measure

  • Comparison of Diastolic Blood Pressure [ Time Frame: up to 30 minutes ]
  • Comparison of Systolic Blood Pressure [ Time Frame: up to 30 minutes ]

Central Contacts and Locations

Central contacts

Mohan Thanikachalam, MD

+1 (617) 639 - 5569admin@dynocardia.care

Gokul Prasath Rajamanickam, MS

gokulpr@dynocardia.care

Locations

Dynocardia Inc

Recruiting

Newton, Massachusetts, United States, 02459

Contacts

Gokul Rajamanickam

gokulpr@dynocardia.care

More Information

Sponsor

Dynocardia, Inc

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Keywords

  • Blood Pressure, Cuff less, Wearable, BP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dynocardia, Inc on 2025-09-05.