RecruitingNCT06149143
Cardiac Performance System Data Collection Study - Minnesota
Sponsor
Sensydia Corporation
Enrollment
50 participants
Start Date
Oct 3, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)
Eligibility
Min Age: 22 Years
Inclusion Criteria3
- Ability to provide written informed consent
- years of age or older
- Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.
Exclusion Criteria4
- Previous Heart Transplant
- Presence of Left Ventricular Assist Device
- Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
- Surgical scars/wounds/bandages/ports at the site of sensor placement
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Interventions
DEVICECardiac Performance System (NSR)
Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06149143
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