Status:
RECRUITING
Cardiac Performance System Data Collection Study - Minnesota
Lead Sponsor:
Sensydia Corporation
Conditions:
Cardiac Disease
Eligibility:
All Genders
22+ years
Brief 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)
Detailed Description
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 Criteria
Inclusion
- Ability to provide written informed consent
- 22 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
- 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
Key Trial Info
Start Date :
October 3 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06149143
Start Date
October 3 2023
End Date
June 30 2024
Last Update
April 17 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455