Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for TAVR, will be enrolled in the 'All Comers Randomized Cohort'. Subjects will be randomized 1:1 to receive either the DurAVR® THV System or any commercially available and approved THV from the SAPIEN series or the Evolut series and followed for 10 years. After completion of the All Comers Randomized Cohort, up to 446 additional low-risk subjects will be randomized 1:1 in the 'Low Risk Randomized Continued Access Cohort'. Up to 150 subjects with a failed surgical bioprosthesis who are deemed high surgical risk and who need valve-in-valve (ViV) TAVR will be enrolled in a separate nested registry (ViV Registry Cohort) and followed for 5 years. Subjects in the ViV Registry Cohort will only receive the DurAVR® THV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,650
Transcatheter aortic valve replacement (TAVR)
Transcatheter aortic valve replacement (TAVR)
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
Composite of all-cause mortality, all stroke and cardiovascular hospitalization
Time frame: 1 Year
All-cause mortality
Mortality from any cause will by collected by tracking patient's living status via medical record
Time frame: 30 Days
Disabling stroke according to VARC-3 Guidelines
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Time frame: 30 Days
Life-threatening bleeding according to VARC-3 Guidelines
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Time frame: 30 Days
Major vascular complication according to VARC-3 Guidelines
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Time frame: 30 Days
Acute Kidney Injury (Stage III or IV) according to VARC-3 Guidelines
The precise categorization is outlined in the Valve Academic Research Consortium-3 (VARC-3) criteria.
Time frame: 30 Days
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