Indicor Validation

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430102
• Other study ID #: Pro00022390
• Status: Completed
• Start date: February 14, 2018
• Est. completion date: March 12, 2020

Study information

• Verified date: June 2020
• Source: Vixiar Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• Indicor
Calculation of LVEDP via analysis of PPG waveform with Valsalva

Locations

Country	Name	City	State
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	Lancaster General Health	Lancaster	Pennsylvania
United States	Christiana Care	Newark	Delaware
United States	Stony Brook Medicine	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vixiar Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (8)

Felker GM, Cuculich PS, Gheorghiade M. The Valsalva maneuver: a bedside "biomarker" for heart failure. Am J Med. 2006 Feb;119(2):117-22. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-LVEDP	Specificity of Calculated LVEDP (C-LVEDP) in identifying invasively Measured LVEDP (M-LVEDP) > 20 mmHg	During patients scheduled left heart cardiac catheterization