SuspendedNot Applicable

Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis

Stopped: No recruitment

Israel100 participantsStarted 2013-12

Plain-language 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.

Who can participate

Age range18 Years – 95 Years

SexALL

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Inclusion criteria

✓. 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
✓. Symptomatic patients with aortic stenosis referred for medically indicated AVR
✓. Signed informed consent to participate in the study.

Exclusion criteria

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

What they're measuring

Change in left ventricular ejection fraction after aortic valve replacement

Timeframe: 2±1 months

Trial details

NCT IDNCT02010177

SponsorSheba Medical Center

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2022-12

View on ClinicalTrials.gov More Aortic Stenosis trials