Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of LVEDP

Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of Left Ventricular End Diastolic Pressure (LVEDP)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02099448

Enrollment

Registered

2014-03-28

Start date

2014-04-30

Completion date

2015-03-31

Last updated

2016-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP using the investigational device C.A 2.0.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Male subject between the ages of 18 - 80 years or postmenopausal female up to 80 years of age 2. Patient undergoing elective cardiac catheterization during which LVED and aortic pressures are recorded 3. Willing and able to sign informed consent prior to study initiation

Exclusion criteria

1. Subject has a baseline heart rate of \< 60 or \>100 beats/min 2. Subject has moderate to severe valvular disease 3. Subject suffers from atrial fibrillation or other tachyarrhythmias 4. Subject suffers from hemodynamic instability 5. Subject is candidate for primary PCI

Design outcomes

Primary

Measure	Time frame
Establish the accuracy of the non-invasive device, C.A 2.0, to estimate LVEDP comparing it to the invasive hemodynamic measurement via left heart catheterization	During elective cardiac catheterization

Countries

Israel

Outcome results