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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Repair of defective aortic valve by microsurgical Intervention.
Klinikum der Universität München-Großhadern
München, Bavaria, Germany
Time to death
All-cause mortality
Time frame: 24 months after last-patient-in
Cardiovascular mortality
Death because of cardiovascular events
Time frame: 5 years after index treatment
Re-hospitalization due to heart failure
Number of hospital stays after randomization
Time frame: 5 years after index treatment
Incidence of neurological events - incidence of strokes
Number of strokes
Time frame: 5 years after randomization
Incidence of neurological Events - incidence of transient ischaemic attacks
Number of transient ischaemic attacks
Time frame: 5 years after randomization
Cardiac functionality - left ventricular function
Echocardiographic measurement of left ventricular ejection fraction in %
Time frame: 5 years after randomization
Cardiac functionality - aortic valve hemodynamics
Measurement of aortic pressure in mmHg
Time frame: 5 years after randomization
Patients' quality of life
EQ5D-score in %
Time frame: 5 years after randomization
Device reliability
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Number of reinterventions (TAVR arm only)
Time frame: 5 years after randomization