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Status:

COMPLETED

Indicor Validation

Lead Sponsor:

Vixiar Medical, Inc.

Conditions:

Heart Failure

Eligibility:

All Genders

18+ years

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 ventri...

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. I...

Eligibility Criteria

Inclusion

  • Adult patients scheduled to undergo a left-heart catheterization that will include the measurement of left ventricular end-diastolic pressure (LVEDP)

Exclusion

  • 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

Key Trial Info

Start Date :

February 14 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 12 2020

Estimated Enrollment :

289 Patients enrolled

Trial Details

Trial ID

NCT03430102

Start Date

February 14 2018

End Date

March 12 2020

Last Update

June 17 2020

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

1

Christiana Care

Newark, Delaware, United States, 19713

2

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States, 08015

3

Stony Brook Medicine

Stony Brook, New York, United States, 11794

4

Lancaster General Health

Lancaster, Pennsylvania, United States, 17603