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Cardiac Performance System Data Collection Study - Minnesota

RECRUITINGSponsored by Sensydia Corporation
Actively Recruiting
SponsorSensydia Corporation
Started2023-10-03
Est. completion2024-06-30
Eligibility
Age22 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 22 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

* 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

Conditions2

Cardiac DiseaseHeart Disease

Locations1 site

University of Minnesota
Minneapolis, Minnesota, 55455
Tamas Alexy

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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