Indicor Validation

NCT03430102 | Completed FDA Device

• 1 other identifier: Pro00022390
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 4

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• C-LVEDP

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

  During patients scheduled left heart cardiac catheterization

Study Arms (1)

LeftHeartCath

Patients scheduled for LV catheterization for direct measurement of LVEDP

Diagnostic Test: Indicor

Interventions

Indicor DIAGNOSTIC_TEST

Calculation of LVEDP via analysis of PPG waveform with Valsalva

LeftHeartCath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vixiar Medical, Inc.: lead

Study Sites (4)

Christiana Care

Newark, Delaware, 19713, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11794, United States

Location

Lancaster General Health

Lancaster, Pennsylvania, 17603, United States

Location

Related Publications (8)

• Gilotra NA, Tedford RJ, Wittstein IS, Yenokyan G, Sharma K, Russell SD, Silber HA. Usefulness of Pulse Amplitude Changes During the Valsalva Maneuver Measured Using Finger Photoplethysmography to Identify Elevated Pulmonary Capillary Wedge Pressure in Patients With Heart Failure. Am J Cardiol. 2017 Sep 15;120(6):966-972. doi: 10.1016/j.amjcard.2017.06.029. Epub 2017 Jun 28.

  PMID: 28754567 BACKGROUND

• Galiatsatos P, Win TT, Monti J, Johnston PV, Herzog W, Trost JC, Hwang CW, Fridman GY, Wang NY, Silber HA. Usefulness of a Noninvasive Device to Identify Elevated Left Ventricular Filling Pressure Using Finger Photoplethysmography During a Valsalva Maneuver. Am J Cardiol. 2017 Apr 1;119(7):1053-1060. doi: 10.1016/j.amjcard.2016.11.063. Epub 2017 Jan 5.

  PMID: 28185634 BACKGROUND

• Silber HA, Trost JC, Johnston PV, Maughan WL, Wang NY, Kasper EK, Aversano TR, Bush DE. Finger photoplethysmography during the Valsalva maneuver reflects left ventricular filling pressure. Am J Physiol Heart Circ Physiol. 2012 May 15;302(10):H2043-7. doi: 10.1152/ajpheart.00609.2011. Epub 2012 Mar 2.

  PMID: 22389389 BACKGROUND

• Sharma GV, Woods PA, Lambrew CT, Berg CM, Pietro DA, Rocco TP, Welt FW, Sacchetti P, McIntyre KM. Evaluation of a noninvasive system for determining left ventricular filling pressure. Arch Intern Med. 2002 Oct 14;162(18):2084-8. doi: 10.1001/archinte.162.18.2084.

  PMID: 12374516 BACKGROUND

• Gillard C, Henuzet C, Lallemand J, Moscariello A, Guillaume M, Van Meerhaeghe A. Operating characteristics of the Finapress system to predict elevated left ventricular filling pressure. Clin Cardiol. 2006 Mar;29(3):107-11. doi: 10.1002/clc.4960290305.

  PMID: 16596832 BACKGROUND

• Zema MJ. Bedside assessment of cardiac hemodynamics: role of the simple Valsalva maneuver. Am J Med. 2012 Aug;125(8):e13; author reply e15-6. doi: 10.1016/j.amjmed.2011.12.020. No abstract available.

  PMID: 22840672 BACKGROUND

• Felker GM, Cuculich PS, Gheorghiade M. The Valsalva maneuver: a bedside "biomarker" for heart failure. Am J Med. 2006 Feb;119(2):117-22. doi: 10.1016/j.amjmed.2005.06.059.

  PMID: 16443410 BACKGROUND

• Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA. 1989 Feb 10;261(6):884-8.

  PMID: 2913385 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Harry Silber, MD, PhD

  Johns Hopkins Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 12, 2018
• Study Start: February 14, 2018
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)