Aortic Valve Calcification, Severe Aortic Valve Stenosis, Symptomatic Aortic Stenosis
Conditions
Keywords
TAVI, TAVR, Transcatheter Aortic Valve Implantation, Transcatheter valve
Brief summary
A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.
Detailed description
The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve. The study will enroll up to 150 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year.
Interventions
DEVICEDurAVR™ THV System
Transcatheter Aortic Valve Implantation (TAVI) Procedure
Sponsors
Anteris Technologies Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Symptomatic, severe aortic stenosis 2. Eligible for delivery of the DurAVR™ THV 3. Anatomy appropriate to accommodate safe placement of DurAVR™ THV 4. Understands the study requirements and the treatment procedures and provides written informed consent. 5. Subject agrees to complete all required scheduled follow-up visits.
Exclusion criteria
Anatomical 1. Anatomy precluding safe placement of DurAVR™ THV 2. Pre-existing prosthetic heart valve in any position 3. Unicuspid or bicuspid aortic valve 4. Severe aortic regurgitation 5. Severe mitral or severe tricuspid regurgitation requiring intervention 6. Moderate to severe mitral stenosis 7. Hypertrophic obstructive cardiomyopathy 8. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment 9. Severe basal septal hypertrophy with outflow gradient Clinical 10. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment 11. Determined inoperable/ineligible for surgery by the Heart Team 12. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure 13. Blood dyscrasias as defined: leukopenia (WBC \< 1000mm3), thrombocytopenia (platelet count \< 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states 14. Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization 15. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support 16. Need for emergency surgery for any reason 17. Ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤ 30% as measured by resting echocardiogram 18. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA) 19. Symptomatic carotid or vertebral artery disease 20. End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min 21. GI bleeding within the past 3 months 22. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, nitinol (titanium or nickel), ticlopidine and clopidogrel, contrast media 23. Ongoing sepsis, including active endocarditis 24. Subject refuses a blood transfusion 25. Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions 26. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent 27. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits) 28. Currently participating in an investigational drug or another investigational device trial 29. Subject belongs to a vulnerable population.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DurAVR™ prosthetic heart valve implant | Immediate post procedure | Number of subjects for which a single DurAVR™ prosthetic heart valve was correctly positioned into the proper anatomical location |
| Hemodynamic performance | Immediate post procedure | Effective Orifice Area (EOA), Mean gradient, Aortic Regurgitation, Paravalvular Leak (PVL), Doppler Velocity Index (DVI) |
| All-cause mortality | 30 days | All-cause mortality |
| Myocardial infarction | 30 days | Myocardial infarction |
| Stroke | 30 days | Disabling Stroke (VARC-3 Guidelines) |
| Life-threatening bleeding | 30 days | Life-threatening bleeding (VARC-3 Guidelines) |
Countries
Georgia
Contacts
STUDY_DIRECTORChris Meduri, MD
Anteris Technologies
Outcome results
None listed