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Cardiac Function Monitoring for Cardiovascular Disease
N/A
Recruiting
Research Sponsored by Sensydia Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 minutes during cardiac catheterization procedure
Awards & highlights
Study 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)
Eligible Conditions
- Cardiovascular Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 minutes during cardiac catheterization procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 minutes during cardiac catheterization procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiac Performance System electronic data for Cardiac Output
Cardiac Performance System electronic data for Pulmonary Artery Pressure
Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Cardiac Function MonitoringExperimental Treatment1 Intervention
Subjects scheduled for cardiac catheterization will undergo measurement with the Cardiac Performance System non-invasive device for a brief period before the catheterization procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cardiac Performance System (NSR)
2020
N/A
~280
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Who is running the clinical trial?
Sensydia CorporationLead Sponsor
3 Previous Clinical Trials
420 Total Patients Enrolled
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