A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves.
The DurAVR™ THV System is a novel balloon-expandable single-piece transcatheter aortic valve. The study will enroll up to 40 subjects with severe, symptomatic native aortic stenosis or with severe degeneration of surgically implanted aortic bioprosthetic valves, with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis. Subjects will be consented for follow-up to 5 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
40
DurAVR™ THV System - Transcatheter Aortic Valve Implantation (TAVI) Procedure
All-cause mortality or disabling stroke
Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines
Time frame: 30 Days
All-cause mortality
Mortality would be reported as rate of death/mortality at 30 days.
Time frame: 30 Days
Disabling stroke
Disabling stroke would be reported according to VARC-3 Guidelines
Time frame: 30 Days
Life-threatening bleeding
Life-threatening bleeding according to VARC-3 Guidelines
Time frame: 30 Days
Major vascular, access-related, or cardiac structural complication
Major vascular, access-related, or cardiac structural complication according to VARC-3 Guidelines
Time frame: 30 Days
Acute kidney injury stage 3 or 4
AKI according to VARC-3 Guidelines
Time frame: 30 Days
Moderate or severe aortic regurgitation
Aortic regurgitation according to VARC-3 Guidelines
Time frame: 30 Days
New permanent pacemaker due to procedure related conduction abnormalities
Rate of pacemaker interventions in subjects experiencing conduction abnormalities (sAS cohort only)
Time frame: 30 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Surgery or intervention related to the device, including aortic valve reintervention
Device related interventions
Time frame: 30 Days