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

NCT04665011 | Completed FDA Device

• 1 other identifier: PROT 000054
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• pulse amplitude ratio

  The correlation between PPG-based and non-invasive blood pressure pulse amplitude ratio during a Valsalva maneuver.

  5 minutes

Secondary Outcomes (1)

• Phases of valsalva pulse response

  5 minuntes

Study Arms (1)

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

Observational to compare simultaneous pulse tracings from PPG and non-invasive blood pressure monitors in capturing the pulse responses to a Valsalva maneuver.

Device: Indicor; Device: Caretaker

Interventions

Indicor DEVICE

A simple, non-invasive tool to report pulse response to a Valsalva maneuver

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

Caretaker DEVICE

non-invasive blood pressure monitor

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study sample has a focus on heart failure patients as this is a clinical target population for the clinical use of the Indicor. However, non-heart failure subjects may be needed to ensure that a range of normal outcome values are included in the analysis. Therefore, at least 70% of the enrollment is intended to be derived from a cardiology practice office, and up to 30% of the enrollment may be non-patient participants.

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

Sponsors & Collaborators

• Vixiar Medical, Inc.: lead

Study Sites (1)

Fort Norfolk Cardiology Associates

Norfolk, Virginia, 23510, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Keith H. Newby, M.D.

  Fort Norfolk Cardiology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 11, 2020
• Study Start: December 14, 2020
• Primary Completion: January 28, 2021
• Study Completion: January 28, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)