Status:
COMPLETED
Validation of Indicor Photoplethysmography (PPG) Valsalva Pulse Response vs Non-invasive Blood Pressure
Lead Sponsor:
Vixiar Medical, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
This study designed is compare the pulse response to the Valsalva maneuver between a photoplethysmography sensor (PPG) and non-invasive blood pressure sensor for the purpose of validating the PPG meth...
Detailed Description
With both a photoplethysmography (PPG; Indicor, Vixiar Medical,. Baltimore, MD) and non-invasive blood pressure (Caretaker, Caretaker Medical, Charlottesville, VA) sensors in place on the index and mi...
Eligibility Criteria
Inclusion
- Clinically stable adults, including heart failure patients visiting an outpatient clinic
Exclusion
- Atrial flutter or atrial fibrillation with an irregular ventricular response
- Significant atrial or ventricular ectopy
- History of paradoxical emboli
- Hypertrophic obstructive cardiomyopathy
- Known intracardiac shunt
- Known severe aortic valve stenosis
- Known severe mitral valve stenosis
- History of embolic CVA
- Myocardial infarction within one week of intended Indicor testing
- Uncontrolled hypertension (systolic BP \>160mmHg or diastolic BP\>100mmHg)
- Hypotension (systolic BP \<90mmHg)
- Symptomatic bradycardia
- Known cholesterol emboli
- Poor left ventricular function with left ventricular thrombus
- Unstable angina
- Significant aortic valvular disease
- Patients weighing less than 40kg
Key Trial Info
Start Date :
December 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 28 2021
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT04665011
Start Date
December 14 2020
End Date
January 28 2021
Last Update
March 16 2021
Active Locations (1)
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1
Fort Norfolk Cardiology Associates
Norfolk, Virginia, United States, 23510