Indicor Validation
- Conditions
- Heart Failure
- Interventions
- Diagnostic Test: Indicor
- Registration Number
- NCT03430102
- Lead Sponsor
- Vixiar Medical, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 289
-Adult patients scheduled to undergo a left-heart catheterization that will include the measurement of left ventricular end-diastolic pressure (LVEDP)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description LeftHeartCath Indicor Patients scheduled for LV catheterization for direct measurement of LVEDP
- Primary Outcome Measures
Name Time Method C-LVEDP During patients scheduled left heart cardiac catheterization Specificity of Calculated LVEDP (C-LVEDP) in identifying invasively Measured LVEDP (M-LVEDP) \> 20 mmHg
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Lancaster General Health
🇺🇸Lancaster, Pennsylvania, United States
Stony Brook Medicine
🇺🇸Stony Brook, New York, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
Christiana Care
🇺🇸Newark, Delaware, United States