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

Completed

• Conditions: Heart Failure

• Registration Number: NCT02099448
• Lead Sponsor: CorAlert Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-26
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-28
• Study Start: 2014-04
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kaplan Medical Center; 🇮🇱 Rehovot, Israel