Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis

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

Status

Suspended

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02010177

Enrollment

100

Registered

2013-12-12

Start date

2013-12-31

Completion date

2024-12-31

Last updated

2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Israel

Outcome results