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Indicor Validation

NCT03430102 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 289

Last updated 2020-06-17

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Indicor

Calculation of LVEDP via analysis of PPG waveform with Valsalva

Sponsors & Collaborators

  • Vixiar Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Harry Silber, MD, PhD · Johns Hopkins Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-14
Primary Completion
2020-03-12
Completion
2020-03-12
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03430102 on ClinicalTrials.gov