Validation of Indicor Photoplethysmography (PPG) Valsalva Pulse Response vs Non-invasive Blood Pressure

Completed

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID: NCT04665011
Run by: Vixiar Medical, Inc.
People needed: 121
Starts: 2020-12-14
Expected to finish: 2021-01-28
Last updated by the study team: 2021-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Clinically stable adults, including heart failure patients visiting an outpatient clinic

You may not qualify if…

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

Where it is running

Fort Norfolk Cardiology Associates — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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