Heart Failure Clinical Trial
Validation of Indicor Photoplethysmography (PPG) Valsalva Pulse Response vs Non-invasive Blood Pressure
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 methodology in deriving a value for the Valsalva pulse response. The aim is to show that the PPG method captures the same phase responses as the blood pressure monitor and the primary outcome is the correlation between pulse amplitude ratios for the pulse at the end of the Valsalva to an average baseline pulse.
Full 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 middle fingers, respectively, each patient will be asked to perform three mild, 10-sec Valsalva maneuvers with at least 45 seconds between. Pulse recordings will be collected from each device to compare phases of the Valsalva pulse response including pulse amplitude changes and baseline movement. The primary outcome is the correlation between pulse amplitude ratios for the pulse at the end of the Valsalva to an average baseline pulse.
Eligibility Criteria
Inclusion Criteria:
Clinically stable adults, including heart failure patients visiting an outpatient clinic
Exclusion Criteria:
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
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There is 1 Location for this study
Norfolk Virginia, 23510, United States
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