Brief Title
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
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.
Study Type
Observational [Patient Registry]
Primary Outcome
Change in left ventricular ejection fraction after aortic valve replacement
Condition
Aortic Stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
100
Start Date
December 2013
Completion Date
June 2021
Primary Completion Date
December 2020
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.
Gender
All
Ages
18 Years - 95 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Israel
Location Countries
Israel
Administrative Informations
NCT ID
NCT02010177
Organization ID
SHEBA-13-0686-IB-CTIL
Responsible Party
Sponsor
Study Sponsor
Sheba Medical Center
Study Sponsor
, ,
Verification Date
April 2018