Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis
Study is aimed to demonstrate that the self-expandable Allegra transcatheter aortic valve implantation (TAVI) system provides lower mean gradient assessed by Transthoracic Echo (TTE) at 30 days post procedure, compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic stenosis. Patients in both arm will receive anticoagulants according to routine practice of the hospital. Patients will be followed-up until 1 year after the procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
130
Patients receive ALLEGRA TAVI System TF. Patient will receive medication according to routine practice of the hospital
Patients receive any kind of CE-marked balloon expandable valve system, used at the hospital. Patient will receive medication according to routine practice of the hospital.
Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
Time frame: At 30 Days
Technical success assessed by composite criteria
* Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Time frame: Up to the end of the time when patient exit the procedure room
Device success assessed by composite criteria
Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * Intended performance of the valve‡ (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)
Time frame: At 30 days
Early safety assessed by composite criteria
* Freedom from all-cause mortality * Freedom from all stroke * Freedom from Valve Academic Research Consortium (VARC) type 2-4 bleeding (in trials where control group is surgery, it is appropriate to include only Type 3 and 4 bleeding) * Freedom from major vascular, access-related, or cardiac structural complication * Freedom from acute kidney injury stage 3 or 4 * Freedom from moderate or severe aortic regurgitation * Freedom from new permanent pacemaker due to procedure-related conduction abnormalities * Freedom from surgery or intervention related to the device
Time frame: At 30 days
Clinical efficacy assessed by composite criteria
* Freedom from all-cause mortality * Freedom from all stroke * Freedom from hospitalization for procedure- or valve-related causes * Freedom from Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score \<45 or decline from baseline of \>10 point (i.e. Unfavourable Outcome)
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Time frame: At 1 year