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Indicor Validation

Sponsor
Vixiar Medical, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03430102
Collaborator
(none)
289
Enrollment
4
Locations
24.9
Actual Duration (Months)
72.3
Patients Per Site
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Indicor

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 Design

Study Type:
Observational
Actual Enrollment :
289 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Validation of the Indicor Device in Identifying Elevated Left Ventricular End Diastolic Pressure LVEDP
Actual Study Start Date :
Feb 14, 2018
Actual Primary Completion Date :
Mar 12, 2020
Actual Study Completion Date :
Mar 12, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. C-LVEDP [During patients scheduled left heart cardiac catheterization]

    Specificity of Calculated LVEDP (C-LVEDP) in identifying invasively Measured LVEDP (M-LVEDP) > 20 mmHg

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Christiana Care Newark Delaware United States 19713
2 Deborah Heart and Lung Center Browns Mills New Jersey United States 08015
3 Stony Brook Medicine Stony Brook New York United States 11794
4 Lancaster General Health Lancaster Pennsylvania United States 17603

Sponsors and Collaborators

  • Vixiar Medical, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Vixiar Medical, Inc.
ClinicalTrials.gov Identifier:
NCT03430102
Other Study ID Numbers:
  • Pro00022390
First Posted:
Feb 12, 2018
Last Update Posted:
Jun 17, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Jun 17, 2020