Brief Title
accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis
Official Title
Optimal Medical Treatment With or Without Valve Repair in Patients With Symptomatic Paradoxical Low-Flow, Low-Gradient Aortic Stenosis - a Multi-center, Randomized Comparison
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, fainting, and chest pain. For many of the patients suffering from severe aortic stenosis surgical or catheter-assisted repair or replacement of the damaged aortic valve has been proven to be a safe and effective treatment option. Probably about 20-30% of patients suffering from severe aortic stenosis display a deviation from the usually observed disease pattern: These patients do not show the typical high pressure difference between the left ventricle (heart chamber) and the aorta (transvalvular gradient; "paradoxical" low flow/low gradient aortic stenosis). For these patients it is not yet clear, if microsurgical repair of the aortic valve (transcatheter aortic valve repair - TAVR) should be a treatment option as well. REBOOT-PARADOX evaluates whether TAVR is advantageous compared to optimal medical Treatment alone for patients suffering from paradoxical aortic stenosis. Two thirds of the participating patients will be treated by TAVR, one third will receive medical Treatment alone.
Study Type
Interventional
Primary Outcome
Time to death
Secondary Outcome
Cardiovascular mortality
Condition
Aortic Valve Stenosis
Intervention
TAVR
Study Arms / Comparison Groups
TAVR Group
Description: Patients will be treated by transcatheter aortic valve repair (TAVR).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
783
Start Date
July 3, 2019
Completion Date
December 2026
Primary Completion Date
July 2026
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Julinda Mehilli, Prof. Dr., +49062159577, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT03863132
Organization ID
REBOOT-PARADOX
Responsible Party
Sponsor
Study Sponsor
IHF GmbH - Institut für Herzinfarktforschung
Collaborators
Boston Scientific Group
Study Sponsor
Julinda Mehilli, Prof. Dr., Principal Investigator, University Clinic Munich
Verification Date
July 2020