Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis

Sheba Medical Center

Status: Suspended

Conditions: Aortic Stenosis

Study type: Observational

Funder types: Other

Identifiers

NCT02010177

SHEBA-13-0686-IB-CTIL

Details and patient eligibility

About

To assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with low-gradient, severe aortic stenosis.

To assess the impact of aortic valve replacement as compared to medical therapy on clinical outcome of patients with low-gradient, severe aortic stenosis.

To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities on the assessment of AS severity and definition of low gradient severe aortic stenosis.

Full description

To assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with impaired left ventricular function and / or low-gradient, severe aortic stenosis.

To assess the impact of aortic valve replacement as compared to medical therapy on clinical outcome of patients with impaired left ventricular function and / or low-gradient, severe aortic stenosis.

To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities on the assessment of AS severity and definition of low gradient severe aortic stenosis.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 and low gradient (mean gradient across the aortic valve <40 mmHg) by echocardiography
2. Symptomatic patients with aortic stenosis referred for medically indicated AVR
3. Signed informed consent to participate in the study.

Exclusion criteria

1. Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).
2. Need for emergency surgery for any reason.
3. Any case in which the practicing physician asserts that enrollment in the protocol will adversely affect the patient treatment course.