Aortic Stenosis Symptomatic
Conditions
Brief summary
First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance of the device.
Detailed description
A single arm, prospective, multicenter, non-randomized, open trial, up to 5 Years follow-up with the Symetis ACURATE TF™ Transfemoral Aortic Bioprosthesis for minimal invasive implantation via transfemoral access to treat patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high risk.
Interventions
DEVICEACURATE TF™ Aortic Valve System
Transcatheter Aortic Valve Implantation
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 75 years of age and older 2. Logistic EuroSCORE ≥ 20% 3. Severe aortic stenosis characterized by mean aortic gradient \> 40 mmHg or peak jet velocity \> 4.0 m/s or aortic valve area \< 1.0 cm2 4. New York Heart Association (NYHA) Functional Class \> II 5. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm measured by TEE 6. Patient not a surgical candidate due to significant co-morbid conditions unrelated to aortic stenosis 7. Patient willing to participate in the study and provide signed informed consent
Exclusion criteria
1. Unicuspid or bicuspid aortic valve 2. Extreme eccentricity of calcification 3. Severe mitral regurgitation ( \>2+) 4. Pre-existing prosthetic heart valve in any position and / or prosthetic ring 5. Aortic or peripheral anatomy NOT appropriate for transfemoral implant 6. Thoracic (TAA) or abdominal (AAA) aortic aneurysm 7. Presence of endovascular stent graft for treatment of TAA or AAA 8. Trans-esophageal echocardiogram (TEE) is contraindicated 9. Left Ventricle Ejection Fraction (LVEF) \< 30% by echocardiography (ECHO) 10. ECHO evidence of intracardiac mass, thrombus, or vegetation 11. Acute Myocardial Infarction (AMI) within 1 month prior to implant procedure 12. Percutaneous Coronary Intervention (PCI), except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure 13. Previous Transient Ischemic Attack (TIA) or stroke within 3 months prior to implant procedure 14. Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure 15. Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit 16. History of bleeding diathesis or coagulopathy or refusal of blood transfusions 17. Systolic pressure \<80 mmHg, cardiogenic shock, need for inotropic support or Intra-Aortic Balloon Pump (IABP) 18. Primary hypertrophic obstructive cardiomyopathy (HOCM) 19. Active infection, endocarditis or pyrexia 20. Hepatic failure 21. Chronic renal dysfunction with serum creatinine \> 2.5 mg/dL or renal dialysis 22. Refusal of surgery 23. Severe Chronic Obstruction Pulmonary Disease (COPD) requiring home oxygen 24. Neurological disease severely affecting ambulation or daily functioning, or dementia 25. Life expectancy \< 12 months due to non-cardiac co-morbid conditions 26. Known hypersensitivity/contraindication to study medication, contrast media, or nitinol 27. Currently participating in an investigational drug or another device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from all-cause mortality | 30-Days | Rate of all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of MACCE (major cardiac and cerebrovascular event) | 30-Days and 12-Months | Rate of major cardiac and cerebrovascular event (MACCE) defined as cardiovascular death, myocardial infarction and stroke |
Countries
Brazil, Germany
Outcome results
None listed