Aortic Stenosis
Conditions
Keywords
Transcatheter Aortic Valve Replacement, TAVI, Transcatheter Aortic Valve Implant, Transfemoral access
Brief summary
Clinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.
Detailed description
Single arm, prospecitve, multicenter, non-randomized and open trial. The purpose of this trial is to collect and safety and performance data concerning the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System The ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis. The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery. The secondary objective is to evaluate adverse events and study device performance.
Interventions
DEVICETranscatheter aortic valve replacement
Transcatheter aortic valve replacement via transfemoral access
Sponsors
Symetis SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient 75 years of age and older 2. Severe aortic stenosis defined as: * Mean aortic gradient \> 40 mmHg or * Peak jet velocity \> 4.0 m/s or * Aortic valve area of \< 1.0 cm2 3. High risk candidate for conventional AVR defined as: * Logistic EuroSCORE 1 ≥ 20% or * STS Score ≥ 8% or * Heart team (cardiologist and cardiac surgeon) consensus that patient is not a surgical candidate for conventional AVR due to significant co-morbid conditions unrelated to aortic stenosis 4. NYHA Functional Class \> II 5. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT 6. Patient willing to participate in the study and provides signed informed consent
Exclusion criteria
1. Congenital aortic stenosis or unicuspid or bicuspid aortic valve 2. Non-stenotic Aortic Insufficiency 3. Severe eccentricity of calcification 4. Severe mitral regurgitation (\>2+) 5. Presence of mitral bioprosthesis 6. Presence of previously implanted aortic bioprosthesis 7. Presence of prosthetic ring 8. Anatomy NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries 9. Thoracic (TAA) or abdominal (AAA) aortic aneurysm 10. Presence of endovascular stent graft for treatment of TAA or AAA 11. Trans-oesophageal echocardiogram (TEE) is contraindicated 12. Evidence of intra-cardiac mass, thrombus or vegetation 13. Severe ventricular dysfunction with ejection fraction \< 20% 14. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure 15. Acute Myocardial Infarction within 1 month prior to implant procedure 16. Previous TIA or stroke within 3 months prior to implant procedure 17. Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure 18. Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit 19. Severe coagulation conditions 20. Refusal of blood transfusions 21. Systolic pressure \<80mmHg, cardiogenic shock, need for inotropic support or IABP 22. Hypertrophic cardiomyopathy with or without obstruction 23. Active bacterial endocarditis or other active infections 24. Hepatic failure (\> Child B) 25. Chronic renal dysfunction with serum creatinine \> 2.5 mg/dL or renal dialysis 26. Refusal of surgery 27. Severe COPD requiring home oxygen 28. Neurological disease severely affecting ambulation or daily functioning, or dementia 29. Life expectancy \< 12 months due to non-cardiac co-morbid conditions 30. Inability to tolerate anticoagulation therapy 31. Contraindication to contrast media or allergy to nickel 32. Currently participating in an investigational drug or another device study 33. Non-valvular aortic stenosis 34. Non-calcific acquired aortic stenosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of all-cause mortality at 30 days follow-up | 30 days post-implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | Day of implant | 2\. Procedural success defined as absence of complications arising during implantation of the prosthetic valve such as: inability to properly seat the valve in the annulus; need for more than one aortic bioprosthesis (valve in valve); or if a surgical aortic valve replacement is required to correct a severe aortic regurgitation or procedure complication |
| Device success | Day of implant | 3\. Device success defined as: * Absence of intra-procedure mortality AND, * Correct positioning of a single prosthetic heart valve into the proper anatomical location AND, * Intended performance of the prosthetic heart valve (EOAi \>0.85 cm2/m2 and mean aortic valve gradient \<20mmHg without moderate or severe AR) |
| VARC Composite Safety at 30 days | 30 days | — |
| Rate of clinical events as defined per VARC guidelines | 7 days, 30 days, 12 months post-implant | Clinical events: * Mortality * Stroke * Myocardial infarction * Bleeding complication * Acute kidney injury * Vascular complication * Conduction disturbances and arrhythmia * Other TAVI-related complications |
| Improvement from baseline in hemodynamic function: effective orifice area, mean transprosthetic gradient | 7 days, 30 days, 12 months | — |
| Total aortic regurgitation | 7 days, 30 days, 12 months | — |
| Clinical improvement from baseline as per NYHA Functional Classification | 7 days, 30 days, 12 months post-implant | — |
Countries
Denmark, Germany, Switzerland
Outcome results
None listed