Status:
ACTIVE_NOT_RECRUITING
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
Lead Sponsor:
IHF GmbH - Institut für Herzinfarktforschung
Collaborating Sponsors:
Boston Scientific Group
Yale University
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Stenosis of the aortic valve leads to a narrowing of the valve, consequently to low blood flow from the heart into the Aorta, and is associated with symptoms like fatigue, breathlessness, dizziness, f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03863132
Start Date
July 3 2019
End Date
March 1 2028
Last Update
May 4 2025
Active Locations (1)
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1
Klinikum der Universität München-Großhadern
München, Bavaria, Germany, 81377