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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

Tracking Information
First Submitted Date December 9, 2013
First Posted Date December 12, 2013
Last Update Posted Date April 17, 2019
Study Start Date December 2013
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 9, 2013)
Change in left ventricular ejection fraction after aortic valve replacement [ Time Frame: 2±1 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02010177 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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.
Condition Aortic Stenosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 9, 2013)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT02010177
Other Study ID Numbers SHEBA-13-0686-IB-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sheba Medical Center
Study Sponsor Sheba Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Sheba Medical Center
Verification Date April 2018