Aortic Stenosis
Conditions
Keywords
TAVI, Aortic Stenosis, transcatether Aortic Valve Implantation
Brief summary
The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System. This device is intended for treatment of subjects with severe aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR) surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive transapical implantation in a well-defined population.
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™TA Delivery System
ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™TA 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
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject must be at least 18 years old 2. Severe aortic stenosis defined as: * Mean aortic gradient \> 40 mmHg or * Peak jet velocity \> 4.0 m/s or * Aortic valve area of \< 0.8 cm2 3. High risk patient determined by a multidisciplinary heart team consensus (cardiologist and cardiac surgeon) that patient is not a surgical candidate for conventional AVR due to risk factors such as STS Score (8% or higher) or other co-morbid conditions unrelated to aortic stenosis such as severe chronic obstructive pulmonary disease (COPD), chest deformities and irradiated mediastinum 4. NYHA Functional Class \> II 5. Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable access route for TAVI due to the presence of the following anatomic conditions: * porcelain aorta or * severely calcified or highly tortuous peripheral vasculature not appropriate for transfemoral transcatheter aortic valve implantation or * vessels too small for retrograde approach or * other anatomical conditions making transapical approach more suitable 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 or non-calcified 2. Extreme eccentricity of calcification 3. Severe mitral regurgitation (\> Grade 3) 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 \< 20% by ECHO 13. Need for emergency intervention for any reason within 30 Days of scheduled procedure 14. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure 15. Untreated clinically significant coronary artery disease requiring revascularization within 30 days before or after the study procedure 16. Acute myocardial infarction within 1 month prior to implant procedure 17. Previous TIA or stroke within 6 months prior to implant procedure 18. Active gastrointestinal (GI) bleeding within 3 months prior to implant procedure 19. Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit 20. History of bleeding diathesis, coagulopathy, refusal of blood transfusions or severe anemia (Hb\<8 g/dL) 21. Systolic pressure \<80mmHg, cardiogenic shock, need for inotropic support or IABP 22. Primary hypertrophic obstructive cardiomyopathy (HOCM) 23. Active infection or endocarditis 24. Hepatic failure (\> Child B) 25. Chronic renal dysfunction with serum creatinine \> 3.0 mg/dL or renal dialysis 26. Neurological disease severely affecting ambulation, daily functioning, or dementia 27. Life expectancy \< 12 months due to non-cardiac co-morbid conditions 28. Intolerance to aspirin, clopidogrel, contrast media, or porcine tissue and allergy to nickel 29. Pregnant or breast-feeding women 30. For other severe illnesses of the patient (e.g. active carcinoma), the investigator shall decide on an individual basis whether the patient is not to be included in the study 31. Currently participating in an investigational drug or another device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Device Performance:Procedure success in absence of MACCE | 30 days post procedure | Procedure success in absence of MACCE |
| Primary Safety: freedom from all-cause mortality | 6 months post procedure | freedom from all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from MACCE at 30 Days, 6 Months and 12 Months | 30 Days, 6 Months and 12 Months | Freedom from MACCE at 30 Days, 6 Months and 12 Months |
| Number of patients who have a Procedural success defined by a combination of criteria | procedure | Procedural success defined as ACURATE neo™ at intended location with |
| Rate of clinical endpoints according to the Valve Academic Research Consortium (VARC 2) guidelines | 30 Days and month 12 | VARC 2 guidelines include different safety and efficacy endpoints like mortality, MI, stroke, etc. |
| NYHA Functional Classification improvement | 30 Days, 6 Month and at 12 Months | NYHA Functional Classification improvement |
| Echocardiographic assessment of valve performance (at 7 Days or Discharge, 30 Days, 6 Months, 12 Months) using a combination of measures | 7 Days or Discharge, 30 Days, 6 Months, 12 Months | Echocardiographic assessment of valve performance (at 7 Days or Discharge, 30 Days, 6 Months, 12 Months) using a combination of measures |
| Rate of device success | 7 days/ Discharge, 30 Days, 6 Months and at 12 Months | Rate of device success |
| Incidence of all cause mortality at 30 Days and 12 Months | 30 days and 12 months | Incidence of all cause mortality at 30 Days and 12 Months |
Countries
Germany
Outcome results
None listed