accuRate Evaluation of Benefit With Optimal Medical Treatment With or Without Transcatheter Valve Repair of PARADOXical Low Flow Low Gradient Aortic Stenosis (REBOOT-PARADOX)

IHF GmbH - Institut für Herzinfarktforschung

Status

Active, not recruiting

Conditions

Aortic Valve Stenosis

Treatments

Device: TAVR

Study type

Interventional

Funder types

Other

Identifiers

NCT03863132

REBOOT-PARADOX

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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