Clinical trial NCT02010177: Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis
Official title: Clinical Outcome of Patients With Low Ejection Fraction or Low-gradient Severe Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Aortic Stenosis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with severe symptomatic aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography, together with low-gradient (mean gradient across the aortic valve \<40 mmHg) who are referred for treatment of AS will be recruited. A total of up to 100 consecutive subjects of both genders will be enrolled at the Sheba Medical Center. The study procedures, clinical management and follow up will be done at the Sheba Medical Center.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in left ventricular ejection fraction after aortic valve replacement
timeFrame: 2±1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References: