Indicor Validation
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/3/2018 |
| Start Date: | February 14, 2018 |
| End Date: | January 20, 2019 |
| Contact: | Thomas Miller, PhD |
| Email: | tmiller@vixiar.com |
| Phone: | (856) 279-1227 |
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.
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.
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.
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.
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
We found this trial at
4
sites
Newark, Delaware 19718
Principal Investigator: Sourin Banerji, MD
Phone: 302-733-4761
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Browns Mills, New Jersey 08015
Principal Investigator: Kulpreet Barn, MD
Phone: 609-893-1200
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Lancaster, Pennsylvania 17601
Principal Investigator: Rahul Jhaveri, MD
Phone: 717-544-1777
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Stony Brook, New York 11794
Principal Investigator: William Lawson, MD
Phone: 631-444-3309
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