A Proof Of Concept study to evaluate the sensitivity and specificity of Wearable and Artificial Intelligence Technology for Chronic Heart Disease used in detecting irregular heart rhythm of patients with Atrial Fibrillation, The POC WATCH AF” study

Not Applicable

• Conditions: Cardiac arrhythmia; Atrial Fibrillation; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12621000849897
• Lead Sponsor: Medical Monitoring Solutions Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-01
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Male or female age equal to or greater than 18 years of age in ICU – 15 patients with atrial fibrillation and 15 in sinus rhythm (may have hypertension or indications of heart failure).
•In the opinion of the Principal Investigator is a suitable candidate for the study.
•Ability to apply morphic sensors at all locations (heart, suprasternal notch, neck, wrist, lower sternum, and temple).

Exclusion Criteria

•Episodes of AF or SR that cannot be documented on ECG.
•Participating in con-current clinical trial which has not met its primary endpoint or in the investigators opinion participation in this study could affect the primary endpoint of the concurrent study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of Saiiv morphic sensors to detection of cardiac rhythm (atrial fibrillation or sinus rhythm) of the heart at various anatomical locations compared to 5 lead ECG . [Day 1];Sensitivity of Saiiv morphic sensors to measure blood pressure at various anatomical locations compared to gold standard radial artery cannulation or non-invasive central blood pressure monitoring. [Day 1];Sensitivity of Saiiv morphic sensors to measure vascular stiffness compared to gold standard pulse wave analysis. [Day 1]