A study to evaluate the accuracy of Wearables and Algorithm Technology for Chronic Heart Disease in the diagnosis of Heart Failure

Not Applicable

Recruiting

• Conditions: Cardiovascular - Coronary heart disease; Heart Failure

• Registration Number: ACTRN12623000038695
• 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: 2023-01-13
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. 18-75 years of age.
2. Diagnosed with Heart Failure (New York Heart Association (NYHA) II to IV) for RHC as part of standard medical care.

Exclusion Criteria

1. Participant is on mechanical ventilation.
2. Participant is receiving cardiac mechanical support.
3. Participant is pregnant or lactating.
4. Inability to place morphic sensors.
5. Participating in a concurrent clinical investigation which has not yet met its primary endpoint, or in the investigator’s opinion, participation in this study would affect the primary endpoint of the concurrent study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
That the morphic sensors can accurately record (greater than or equal to 90% value comparison) Pulse Wave Volocity as compared to the SphygmoCor XCEL device (within a 95% Confidence Interval.)[ During Invasive and Non-invasive study];That the morphic sensors can accurately record (greater than or equal to 90% value comparison) Central Blood Pressure as compared to the SphygmoCor XCEL device (within a 95% Confidence Interval.)[ During Invasive and Non-invasive study];That the morphic sensors can accurately record (greater than or equal to 90% value comparison) Peripheral Blood Pressure as compared to the SphygmoCor XCEL device and BioPac device (within a 95% Confidence Interval.)[ During Invasive and Non-invasive study]