At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Validation of the Indicor Device in Identifying Elevated Left Ventricular End Diastolic Pressure LVEDP
In Brief
An observational study evaluating Indicor for Heart Failure. Completed, enrolled 289 participants across 4 sites.
Detailed Summary
The study is designed to repeat an initial training set study conducted at Johns Hopkins Medical Center, comparing a new investigational device, Indicor, a non-invasive tool for estimating left ventricular end diastolic pressure (LVEDP), to the gold standard, invasively measured LVEDP via direct measurement via left heart catheterization. The study is divided into an initial training set, followed by the validation set which is designed to support an FDA 510(k) submission and validate the final algorithm. Patients will be enrolled who are scheduled to undergo a cardiac catheterization and will be asked to perform three tests with the Indicor.
Study Details
Timeline
Interventions
Calculation of LVEDP via analysis of PPG waveform with Valsalva