Aortic Symptomatic Stenosis
Conditions
Keywords
Severe Symptomatic Aortic Valve Stenosis
Brief summary
The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.
Detailed description
A single arm, prospective, multicenter, non-randomized, and open trial, up to 5 years follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation vie transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating safety and performance of the implantation and safety at 30-D follow-up.
Interventions
DEVICEACURATE TA™
ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement Surgery.
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. Patients at least 75 years of age 2. Additive EuroSCORE \> 9 3. Severe AS assessed by echocardiography and documented by a mean gradient \> 40mmHg and a native Aortic Valve Area (AVA) \< 0.8 cm² or Aortic Valve Area Index (AVAI) \< 0.6 cm²/m² 4. NYHA Functional Class \> II 5. Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography (TEE) 6. Patient understands the implications of participating in the study and provides signed informed consent
Exclusion criteria
1. Congenital unicuspid or bicuspid aortic valve 2. Severe eccentricity of calcification 3. Severe mitral regurgitation (\> 2°) 4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring 5. Severe transapical access problem, non-reachable LV apex 6. Previous surgery of the LV using a patch, such as the Dor procedure 7. Presence of apical LV thrombus 8. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation 9. Acute myocardial infarction (AMI) within 1 month prior to the procedure 10. PCI within 1 month prior to the procedure 11. Previous transient ischemic attack (TIA) or stroke in the last 3 months 12. Untreated clinically significant coronary artery disease (CAD) requiring revascularization 13. Hemodynamic instability: systolic pressure \<90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump 14. Severe left ventricular dysfunction (LVEF) \< 30% by echocardiography 15. Calcified pericardium 16. Septal hypertrophy unacceptable for transapical procedure 17. Primary hypertrophic obstructive cardiomyopathy (HOCM) 18. Active infection, endocarditis or pyrexia 19. Active peptic ulcer or gastrointestinal (GI) bleeding within the past 3 months 20. Significant hepatic involvement (Child \> B) 21. Severe COPD requiring home oxygen 22. History of bleeding diathesis or coagulopathy 23. Hematologic disorder (WBC \< 3000mm3, Hb \< 9g/dL, platelet count \< 50000 cells/ mm3) 24. Chronic renal dysfunction with a serum creatinine level \> 2.5 mg/dL or renal failure requiring dialysis 25. Neurological disease severely affecting ambulation or daily functioning, including dementia 26. Another surgical or percutaneous procedure scheduled at the same time 27. Emergency procedure 28. Life expectancy \< 12 months due to non-cardiac co-morbid conditions 29. Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol 30. Currently participating in an investigational drug or another device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from all-cause mortality at 30 day Follow Up | 30-Day Follow-up | The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 30 days post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery. |
| Freedom from all-cause mortality at 12 months Follow Up | 12 months Follow-Up | The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 12 months post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Improvement from baseline | 30-Days and 12-Month Follow-up | per NYHA functional classification |
| Rate of Major Adverse Valve-Related Events (MAVRE) at 30 days and at 12 month follow up related to the study device as defined as; | 30-Days and at 12 Months Follow-up | 2.1 Structural valve deterioration 2.2 Non-structural dysfunction of the implanted study device 2.3 Valve thrombosis, embolism, bleeding event 2.4 Operated valve endocarditis 2.5 Re-intervention on the implanted device 2.6 Valve-related mortality 2.7 Need for new permanent pacemaker or defibrillator within 14 days |
| Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab. | 30-Day and 12-Month Follow-up | Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab. The following datapoints will be analyzed: 6.1 Effective orifice area and index (EOA/EOAI) 6.2 Transvalvular Gradients (Peak and mean) 6.3 Paravalvular and intravalvular (Central) leaks 6.4 Aortic Insufficiency 6.5 LV function and hemodynamics 6.6 Valve function and morphology |
| Procedural success | 24 hours Post-Procedure | defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography as assessed at a Core Lab and without intraprocedural mortality. |
| Rate of Major Adverse Cardiac and Cerebrovascular-Related Events (MACCE) at 30 days and at 12 Month and defined as cardiovascular death, myocardial infarction and stroke. | 30-Day and 12-Month | Defined as cardiovascular death, myocardial infarction and stroke |
Countries
Germany
Outcome results
None listed