Indicor Validation
Completed
Conditions studied: Heart Failure
In brief
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.
Key facts
- Study ID
- NCT03430102
- Run by
- Vixiar Medical, Inc.
- People needed
- 289
- Starts
- 2018-02-14
- Expected to finish
- 2020-03-12
- Last updated by the study team
- 2020-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Christiana Care — Newark, Delaware, United States
- Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
- Stony Brook Medicine — Stony Brook, New York, United States
- Lancaster General Health — Lancaster, Pennsylvania, United States
Full record on ClinicalTrials.gov
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