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Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis

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ClinicalTrials.gov Identifier: NCT02010177
Recruitment Status : Recruiting
First Posted : December 12, 2013
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Clinical Outcome of Patients With Low Ejection Fraction or Low-gradient Severe Aortic Stenosis
Study Start Date : December 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in left ventricular ejection fraction after aortic valve replacement [ Time Frame: 2±1 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010177


Locations
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Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Israel Barbash, MD    97235305273    ibarbash@gmail.com   
Sponsors and Collaborators
Sheba Medical Center

Additional Information:

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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02010177     History of Changes
Other Study ID Numbers: SHEBA-13-0686-IB-CTIL
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2018

Additional relevant MeSH terms:
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Constriction, Pathologic
Aortic Valve Stenosis
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction