An interventional study of Vivio System in Aortic Stenosis, sponsored by Ventric Health, LLC. Withdrawn at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-20.
Sponsored by Ventric Health, LLC · Not applicable, Interventional, and Diagnostic
Optimize a candidate software algorithm using data collected with the Vivio system for use as an aid in the identification of heart sounds associated with severe aortic stenosis
Prospective, non-randomized, single-center study of adult subjects referred for echocardiography. Total of 200 enrolled subjects at 1 site
Enrolled subjects will undergo:
Vivio system data capture, standard of care transthoracic echocardiogram (TTE). Vivio analysis will not be available to non-Avicena personnel
1,006 studies on the registry are indexed under Aortic Valve Stenosis; 284 are open to participants now.
Browse Aortic Valve Stenosis studies →Ventric Health, LLC is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Device: Vivio System
The Vivio System is an electronic auscultatory device and optical sensor, plus software application intended to provide support to the physician in the evaluation of heart sounds in patients. The product will analyze the acoustic signals of the heart and signals from a captured arterial (carotid) waveform. The analysis procedure will identify and analyze specific heart sounds and arterial waveform features captured by the Vivio device, to devise a scoring system for severe aortic stenosis.
Primary Endpoint - Generation of an optimized algorithm that can be used to develop an algorithm for use as an aid in the identification of heart sounds associated with severe aortic stenosis.
Generation of an optimized algorithm that can be used to develop an algorithm for use as an aid in the identification of heart sounds associated with severe aortic stenosis.
Time frame: 48 hours
Secondary Endpoint - Incidence of Adverse Events: Summary of all reported adverse events during the study
Incidence of Adverse Events: Summary of all reported adverse events during the study. Events will be summarized by seriousness (e.g. serious vs. non-serious), attribution (e.g. device vs. procedure vs. comorbidity) based upon site reported data.
Time frame: 48 hours
Ran from Jun 2019 to primary completion in Aug 2019, 2 months.
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This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Ventric Health, LLC