Indicor Validation

June 16, 2020 updated by: Vixiar Medical, Inc.

Validation of the Indicor Device in Identifying Elevated Left Ventricular End Diastolic Pressure LVEDP

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who are scheduled to undergo a left heart cardiac catheterization for direct measure of left ventricular end diastolic pressure (LVEDP) as part of routine care will be asked to participate. Investigators will take non-invasive measures of LVEDP using the Indicor device, repeated at three time points before and after the catheterization procedure. The Indicor indirectly measures LVEDP by calculating a value from finger photoplethysmography (PPG) waveforms that will be recorded while the patient performs a Valsalva maneuver.

Participants baseline characteristics will be gathered from the electronic medical record, including history of coronary artery disease, heart failure, hypertension, diabetes, or lung disease; list of blood pressure medications; serum markers of kidney function; and echocardiogram measurements including ejection fraction. These parameters will be used to assess relevance to the calculation of LVEDP by Indicor.

The first Indicor measure will be conducted before the catheterization procedure. PPG probes will be attached to participants' first or second finger. Participants will be asked to strain as if having a bowel movement (Valsalva maneuver) for 10 seconds. Participants will blow into a pressure transducer that measures and displays the pressure of their effort. The Indicor device will acquire 3 successful efforts.

During the cardiac catheterization, while the pressure transducer used by the clinical team to measure LVEDP is in the aorta, the Valsalva testing will be repeated. The device will again acquire 3 successful efforts. This will allow investigators to determine how well the amplitude changes of the PPG signal during Valsalva maneuver reflect the amplitude changes of central arterial pressure during the Valsalva maneuver. According to experienced catheterization cardiologists, this set of tests will not add significant risk to the procedure. This second set of tests may not be performed in all participants.

Immediately after the cardiac catheterization, while the patient is still on the catheterization table, the Valsalva testing will be repeated. The device will again acquire 3 successful efforts.

Study Type

Observational

Enrollment (Actual)

289

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Care
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
    • New York
      • Stony Brook, New York, United States, 11794
        • Stony Brook Medicine
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17603
        • Lancaster General Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled to undergo cardiac catheterization as part of their routine care and clinically indicated

Description

Inclusion Criteria:

-Adult patients scheduled to undergo a left-heart catheterization that will include the measurement of left ventricular end-diastolic pressure (LVEDP)

Exclusion Criteria:

  • Weight <88 pounds (40 kilograms)
  • Atrial flutter or atrial fibrillation with an irregular ventricular response
  • Significant atrial or ventricular ectopy
  • History of paradoxical emboli
  • Hypertrophic obstructive cardiomyopathy
  • History of paradoxical emboli
  • Known intracardiac shunt
  • Known severe aortic valve stenosis or known severe mitral valve stenosis
  • History of embolic cerebrovascular accident
  • Clinically unstable
  • Uncontrolled hypertension (systolic BP >160 mmHg or diastolic BP> 100 mmHg)
  • Hypotension (systolic BP <90 mmHg)
  • Symptomatic bradycardia
  • Known cholesterol emboli
  • Poor LV function with known LV thrombus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LeftHeartCath
Patients scheduled for LV catheterization for direct measurement of LVEDP
Diagnostic test: Indicor
Calculation of LVEDP via analysis of PPG waveform with Valsalva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-LVEDP
Time Frame: During patients scheduled left heart cardiac catheterization
Specificity of Calculated LVEDP (C-LVEDP) in identifying invasively Measured LVEDP (M-LVEDP) > 20 mmHg
During patients scheduled left heart cardiac catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vixiar Medical, Inc.

Investigators

  • Principal Investigator: Harry Silber, MD, PhD, Johns Hopkins Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2018

Primary Completion (Actual)

March 12, 2020

Study Completion (Actual)

March 12, 2020

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

February 9, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00022390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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