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

CorAlert

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT02099448

COR-01

Details and patient eligibility

About

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

Enrollment: 41 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

41 participants in 1 patient group

Elective Cardiac Catheterization