Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02010177
• Other study ID #: SHEBA-13-0686-IB-CTIL
• Status: Suspended
• Start date: December 2013
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricular ejection fraction after aortic valve replacement		2±1 months