narrowing of heart valve Stenosis of Aortic valve
Conditions
Interventions
Transfemoral inplantation of the SJM Portico Transcatheter Aorta Valve.
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject has given written study Informed Consent for participation prior to procedure. 2. Subject is >= 18 years of age or legal age in host country. 3. Subject*s aortic annulus diameter meets the range indicated in the Instructions for Use as measured by CT conducted within the past 120 days, or echocardiogram (TEE 3D recommended) if medically contraindicated to CT. 4. Subject has senile degenerative aortic stenosis with echocardiography derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of
Exclusion criteria
Exclusion criteria: 1. Subject has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months ( grade III) or moderate to severe mitral stenosis. 7. Subject has aortic root angulation >70 degrees (horizontal aorta). 8. Subject has a pre-existing prosthetic valve or prosthetic ring in any position. 9. Subject refuses blood transfusion or surgical valve replacement. 10. Subject has resting left ventricular ejection fraction (LVEF) 3.0 mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic dialysis. 22. Subject has morbid obesity defined as BMI >= 40. 23. Subject*s iliac arteries have severe calcification, tortuosity (>two 90 degree bends), diameter = 4cm o thoracic aneurysm (defined as a maximal luminal diameter of 5 cm or greater) o marked tortuosity o significant aortic arch atheroma or narrowing of the abdominal or thoracic aorta o severe tortuosity of the thoracic aorta. 28. Subject has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries. 29. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to the index procedure. 30. Subject is currently participating in another in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is all cause mortality at 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The event rates at 30 days of the following: • Cardiovascular mortality • Myocardial Infarction (MI) • Disabling stroke (Major Stroke) • Non-disabling stroke (Minor Stroke) • Acute kidney injury (AKI) • Vascular access site and access-related complications • Bleeding • Composite of o periprocedural encephalopathy o all stroke o all TIA 2. Functional improvement from baseline as compared to 30 days by: a. NYHA Functional Classification b. Six Minute Walk Test c. Effective Orifice Area (EOA) 3. Acute device success defined as: a. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system b. Correct position of the device in the proper anatomical location c. Intended performance of the prosthetic heart valve (Aortic Valve Area >1.2 cm2 and mean aortic valve gradient | — |
Countries
Netherlands
Outcome results
None listed