An observational study in Heart Failure, sponsored by Vixiar Medical, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-16.
Sponsored by Vixiar Medical, Inc. · Observational
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.
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.
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.
Exclusion Criteria:
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
A simple, non-invasive tool to report pulse response to a Valsalva maneuver
non-invasive blood pressure monitor
pulse amplitude ratio
The correlation between PPG-based and non-invasive blood pressure pulse amplitude ratio during a Valsalva maneuver.
Time frame: 5 minutes
Phases of valsalva pulse response
The agreement between PPG-based and non-invasive blood pressure pulse tracings during a Valsalva maneuver.
Time frame: 5 minuntes
Plan to share: No
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Vixiar Medical, Inc.