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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099448
• Other study ID #: COR-01
• Status: Completed
• Phase: N/A
• First received: March 26, 2014
• Last updated: February 8, 2016
• Start date: April 2014
• Est. completion date: March 2015

Study information

• Verified date: February 2016
• Source: CorAlert Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Israel	Kaplan Medical Center	Rehovot

Sponsors (1)

Lead Sponsor	Collaborator
CorAlert Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No