Aortic Stenosis
Conditions
Keywords
TAVI, Aortic Stenosis, Transcatether Aortic Valve Implantation
Brief summary
Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device
Detailed description
This is a single arm, prospective, multicenter non randomised and open trial of the treatment of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be high risk. All patients will be followed up to 5 years after the intervention. The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis considered to be high risk for surgery Secondary objective is to evaluate adverse events and study device performance.
Interventions
DEVICEACURATE neo™ and ACURATE TA™ LP
ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk
Sponsors
Symetis SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Medical device trial
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 \> 40mmHg or o Peak jet velocity \> 4.0m/sor Aortic valve area of \< 1.0cm2 3. High risk candidate for conventional AVR defined as: STS score ≥ 10 or Multidisciplinary 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. Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable TAVI access route 6. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE 7. Patient willing to participate in the study and provides signed informed consent
Exclusion criteria
1. Congenital unicuspid or bicuspid aortic valve 2. Extreme eccentricity of calcification 3. Severe mitral regurgitation (\> Grade 2) 4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring 5. LV apex is not accessible via transapical access due to severe chest deformity 6. Previous surgery of the LV using a patch, such as the Dor procedure 7. Presence of apical LV thrombus 8. Calcified pericardium 9. Septal hypertrophy unacceptable for transapical procedure 10. Transesophageal echocardiogram (TEE) is contraindicated 11. ECHO evidence of intracardiac mass, thrombus, or vegetation 12. LVEF \< 30% by ECHO 13. Emergency procedure pre-implant including CAD requiring revascularization 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 gastrointestinal (GI) bleeding within 3 months prior to implant procedure 18. Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit 19. History of bleeding diathesis or coagulopathy or refusal of blood transfusions 20. Systolic pressure \<80mmHg, cardiogenic shock, need for inotropic support or IABP 21. Primary hypertrophic obstructive cardiomyopathy (HOCM) 22. Active infection, endocarditis or pyrexia 23. Hepatic failure (\> Child B) 24. Chronic renal dysfunction with serum creatinine \> 2.5 mg/dL or renal dialysis 25. Refusal of surgery 26. Severe COPD requiring home oxygen 27. Neurological disease severely affecting ambulation, daily functioning, or dementia 28. Life expectancy \< 12 months due to non-cardiac co-morbid conditions 29. Contraindication to study medication, contrast media, or allergy to nitinol 30. Currently participating in an investigational drug or another device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 30 days | incidence of all cause mortality at 30 days |
| Mean aortic gradient after device implantation | 7 days or Discharge | mean aortic gradient evaluated by echocardiography and by the site at 7days or discharge per standard post-implantation follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of clinical endpoints VARC II | 30 days and month 12 | rate of clinical endpoints VARC II at 30 days and 12 months |
| procedural success | procedure | procedural success defined as ACURATE neo™ at intended location |
| device success assessed according to composite VARC 2 criteria | 7 days, 30 days, 12 months | Device success defined as: * ACURATE neo™ implanted in intended location * No impingement of the mitral valve * Normal coronary blood flow * Insufficiency \< Grade 3 * Mean aortic gradient \< 20mmHg * EOA ≥ 1.0 cm2 No further re-intervention performed on the ACURATE neo™ implant |
| functional improvement from Baseline as per NYHA Functional Classification | 30 days and 12 months follow up | functional improvement from baseline as per NYHA functional classification at 30 days and 12 months follow up |
Countries
Germany
Outcome results
None listed