I35.0
Conditions
Interventions
Group 1: The trial contains only one treatment arm. All patients will be treated with the ACURATE neo TF bioprosthesis implanted via a minimal invasive access of the transfemoral artery.
Sponsors
Symetis SA
Eligibility
Sex/Gender
All
Age
75 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patient 75 years of age and older 2. Severe aortic stenosis defined as: o Mean aortic gradient > 40 mmHg or o Peak jet velocity > 4.0 m/s or o Aortic valve area of II 5. Aortic annulus diameter from = 21mm up to = 27mm by CT or TEE 6. Patient willing to participate in the study and provides signed informed consent
Exclusion criteria
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. ECHO evidence of intracardiac mass, thrombus, or vegetation 10. LVEF Child B) 21. Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis 22. Refusal of surgery 23. Severe 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. Contraindication to study medication, contrast media, or allergy to nitinol 27. Currently participating in an investigational drug or another device study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint The primary safety endpoint is incidence of all-cause mortality at 30 days. Primary Device Performance Endpoint The primary device performance endpoint is a mean aortic gradient, as evaluated by echocardiography and evaluated by the site at 7 days or discharge per standard postimplantation follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints Secondary endpoints are defined as below: 1. Rate of clinical endpoints (VARC 2) at 30 days and at 12 months: • Mortality • Stroke • Myocardial infarction • Bleeding complication • Acute kidney injury • Vascular complication • Conduction disturbances and arrhythmia • Other TAVI-related complications 2. Procedural success defined as ACURATE TF™ in intended location with: • Insufficiency < Grade 3 • Mean aortic gradient < 20 mmHg • EOA = 1.0 cm2 • No further re-intervention performed on the ACURATE TF™ implant 3. Device success at 7 days or discharge and at 12 months follow-up defined as: • ACURATE TF™ 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 TF™ implant 4. Functional improvement from baseline as per NYHA Functional Classification at 30 days and at 12 months follow-up | — |
Countries
Germany
Contacts
Public ContactHelge Möllmann
St.-Johannes Hospital Dortmund
Outcome results
None listed