Cardiac CT for therapeutic stratification in low gradient presumed severe aortic stenosis with preserved left ventricular ejection fractio

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

1. Written informed consent
2. Echocardiographic severe aortic valve stenosis with aortic valve area <1.0
cm2
3. Preserved left ventricular ejection fraction (LVEF), defined as LVEF at
least 50%
4. Low mean transvalvular aortic pressure gradiënt (<40 mmHg)
5. Age at least 60 years
6. Patient has suitable anatomy to allow transcatheter aortic valve implantation
7. Patient demonstrates symptoms suspicious of heart failure or severe aortic
valve stenosis

Exclusion Criteria

1.Hypersensitivity or contraindication to aspirin, heparin, clopidogrel or
sensitivity for contrast media which cannot be adequately pre-medicated
2.Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia
(platelet count <50,000 cells/mm3), history of bleeding diathesis or
coagulopathy
3.Concomitant valvular disease, defined as more than moderate aortic valve
regurgitation, and/or more than moderate mitral valve regurgitation and/or
stenosis.
4.Ongoing sepsis, including active endocarditis
5.Symptomatic carotid or vertebral artery disease or successful treatment of
carotid stenosis within 6 weeks of inclusion
6.Active gastrointestinal (GI) bleeding within the past 3 months
7.Subject refuses blood transfustion
8.Severe dementia
9.Estimated life expectancy of less than 24 months due to associated
non-cardiac comorbidities
10.Other medical, social, or psychological conditions that in the opinion of
the investigator precludes the subject form appropriate consent or adherence to
the protocol required follow-up exams
11.Reduced LV function (LVEF <50%)
12.Native aortic annulus size <18 mm or >30 mm per baseline diagnostic imaging
13.sinus of valsalva diameter <25 mm or sinus of valsalva height <15 mm
14.Concomitant planned coronary artery bypass graft or additional valve
intervention
15.Hypertrophic obstructive cardiomyopathy
16.Echocardiographic or CT evidence of intracardiac mass, thrombus or vegetation
17.Transarterial access not able to accommodate an 18Fr sheath
18.Patient not being able to exercise or perform 6 MWT

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The co-primary endpoints of this trial are:<br /><br>Change in exercise capacity assessed by CPET (peak VO2) and 6 minute walk test<br /><br>(6MWT) from baseline to 6 months in patients with NF/LG and LF/LG severe AS<br /><br>with preserved LVEF reclassified from severe to moderate AS with fusion AVA<br /><br>1.0-1.2 cm2.</p><br>

Secondary Outcome Measures