Clinical trial NCT03430102: Indicor Validation
Official title: Validation of the Indicor Device in Identifying Elevated Left Ventricular End Diastolic Pressure LVEDP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Vixiar Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-12
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo cardiac catheterization as part of their routine care and clinically indicated

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: C-LVEDP
timeFrame: During patients scheduled left heart cardiac catheterization
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Lancaster
country: United States
facility: Lancaster General Health
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins Medical Center
name: Harry Silber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.