Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis

Clinical Outcome of Patients With Low Ejection Fraction or Low-gradient Severe Aortic Stenosis

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.

Study Overview

• Status: Suspended
• Conditions: 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
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in left ventricular ejection fraction after aortic valve replacement	2±1 months

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2022
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 9, 2013
• First Submitted That Met QC Criteria: December 9, 2013
• First Posted (Estimated): December 12, 2013

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: SHEBA-13-0686-IB-CTIL