Remote Cardiac Monitoring by the Corsano CardioWatch 287-2 Evaluation Study

Completed

• Conditions: atrial fibrillation; hypertension; high blood pressure; 10007521; 10057166

• Registration Number: NL-OMON56059
• Lead Sponsor: Corsano Health B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-12-28
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 190

Inclusion Criteria

* >= 18 years old;
* able to provide consent;
* receiving EKG holter or automatic blood pressure cuff for home monitoring per
doctor prescription

Exclusion Criteria

* unable to wear the Corsano CardioWatch 287 due to reasons such as allergic
reactions, wounds, amputations etc.;
* unable to receive blood pressure measurements per cuff due to lymphedema,
amputation, dyalisis shunt, wounds, etc.;
* pregnant women;
* breastfeeding women;
* upper arm circumference not within the cuff range (22-42 cm)
* unable or not willing to sign informed consent;
* significant mental or cognitive impairment

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Absolute percentage increase of patients in whom at least one event of atrial<br /><br>fibrillation is detected by the Corsano CardioWatch 287-2 during 28 days of<br /><br>monitoring, compared to a conventional EKG holter during 24-48 hours of<br /><br>monitoring.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(1) Mean blood pressure difference and its SD between blood pressure measured<br /><br>by the Corsano CardioWatch 287-2 and blood pressure measured by a conventional<br /><br>oscillometric blood pressure cuff.<br /><br>(2) Usability of the Corsano CardioWatch 287-2 in a remote care setting as<br /><br>determined by a questionnaire.<br /><br>(3) Difference between awake-asleep blood pressure change as measured by the<br /><br>Corsano CardioWatch 287-2 and awake-asleep blood pressure change as measured by<br /><br>a conventional 30-min. oscillometric blood pressure cuff across 24 hours. </p><br>