accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
TAVR: Repair of defective aortic valve by microsurgical Intervention.
Study summary
Aim of this study is to evaluate whether microsurgical repair or replacement of the aortic valve is a treatment option for a subgroup of patients suffering from aortic Stenosis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* I1. Patients with symptomatic native aortic valve stenosis and age ≥18 years
* I2. Aortic valve area (AVA) ≤ 1 cm2 or indexed AVA ≤ 0.6 cm2/m2, mean aortic gradient \< 40 mmHg and stroke volume index (SVI) \< 35ml/m2
* I3. Left ventricular ejection fraction ≥ 50%
* I4. MDCT aortic valve calcium score men \> 2000AU, women \> 1200AU OR the likelihood criteria are fulfilled (symptoms without other explanation and LV hypertrophy; age \< 70 yrs., AVS \< 0.8 cm2; SVI \< 35ml/m2 confirmed by 3D TOE, MRI or invasive; reduced LV longitudinal function without other reason)
* I5. Heart team agrees on eligibility for TAVR
* I6. Written informed consent
* I7. Negative pregnancy test in women with childbearing potential
Exclusion Criteria:
* E1. Hemodynamic instability
* E2. Cardiogenic shock
* E3. Pre-existing mechanical or bio-prosthetic valve in any position
* E4. Concomitant severe valvular heart disease
* E5. Pre-existing or active endocarditis
* E6. Need for heart surgery due to other conditions
* E7. Aortic valve is congenital unicuspid or congenital bicuspid
* E8. Hypertrophic cardiomyopathy with or without obstruction
* E9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
* E10. Acute myocardial infarction within 1 month before intended AS-treatment
* E11. Renal replacement therapy
* E12. Estimated life expectancy \< 24 months (730 days) due to carcinomas end stage liver disease or renal disease
* E13. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
* E14. Patient refuses aortic valve repair
Primary outcome measure(s)
Time to death — 24 months after last-patient-in All-cause mortality
Trial sites (1)
Facility
City
Region
Status
Klinikum der Universität München-Großhadern
München
Bavaria
More IHF GmbH - Institut für Herzinfarktforschung trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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