Aortic Valve Calcification, Aortic Valve Disease, Aortic Valve Failure, Severe Aortic Valve Stenosis, Symptomatic Aortic Stenosis
Conditions
Keywords
Transcatheter Aortic Valve Implantation (TAVI), Transcatheter Aortic Valve Replacement (TAVR), Transcatheter Valve, Valve-in-Valve, Aortic Valve Disease
Brief summary
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.
Detailed description
The DurAVR™ THV System is a novel balloon-expandable single-piece transcatheter aortic valve. The study will enroll up to 15 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.
Interventions
DEVICEDurAVR™ THV System
DurAVR™ THV System - Transcatheter Aortic Valve Implantation (TAVI) Procedure
Sponsors
Anteris Technologies Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older. 2. Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team 3. Eligible for transfemoral delivery of the DurAVR™ THV 4. Anatomy appropriate to accommodate safe placement of DurAVR™ THV 5. Understands the study requirements and the treatment procedures and provides written informed consent 6. Subject agrees to complete all required scheduled follow-up visits.
Exclusion criteria
1. Anatomy precluding safe placement of DurAVR™ THV 2. Pre-existing prosthetic mitral or tricuspid valve 3. Unicuspid, bicuspid or non-calcified aortic valve 4. Severe mitral or severe tricuspid regurgitation requiring intervention 5. Moderate to severe mitral stenosis 6. Hypertrophic obstructive cardiomyopathy 7. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment 8. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment 9. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure 10. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA) 11. End-stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min 12. GI bleeding within the past 3 months 13. Ongoing sepsis (including active endocarditis) or endocarditis in the last 3 months 14. Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality or disabling stroke | 30 Days | Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 30 Days | Mortality would be reported as rate of death/mortality at 30 days. |
| Disabling stroke | 30 Days | Disabling stroke would be reported according to VARC-3 Guidelines |
| Life-threatening bleeding | 30 Days | Life-threatening bleeding according to VARC-3 Guidelines |
| Major vascular, access-related, or cardiac structural complication | 30 Days | Major vascular, access-related, or cardiac structural complication according to VARC-3 Guidelines |
| Acute kidney injury stage 3 or 4 | 30 Days | AKI according to VARC-3 Guidelines |
| Moderate or severe aortic regurgitation | 30 Days | Aortic regurgitation according to VARC-3 Guidelines |
| New permanent pacemaker due to procedure related conduction abnormalities | 30 Days | Rate of pacemaker interventions in subjects experiencing conduction abnormalities (sAS cohort only) |
| Surgery or intervention related to the device, including aortic valve reintervention | 30 Days | Device related interventions |
Countries
Denmark
Outcome results
None listed