Aorta Valve Stenosis Narrowing of the heart valve
Conditions
Interventions
Transapical inplantation of the SJM Portico Transcatheter Aorta Valve.
Safety
TAVI
Transapical
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject has given written study Informed Consent. 2. Subject is 65 years of age or older at the time of index procedure, and/or has comorbidities that, in the opinion of the Principle Investigator or the Subject Selection Committee, preclude surgical valve replacement. 3. Subject*s aortic annulus diameter meets the range indicated in the Instructions for Use as measured by multi-slice CT conducted within the past 120 days prior to the index procedure. 4. Subject has senile degenerative aortic stenosis with echocardiography within 30 days of index procedure defined by at least 1 of the following: derived mean gradient >40mmHg OR jet velocity greater than 4.0 m/s OR aorta valve area of *1.0 cm2 OR aortic valve area index * 0.6 cm2/m2). 5. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III or IV. 6. Subject is deemed high operable risk and delivery route is suitable for TAVI per the medical opinion of the Subject Selection Committee. 7. Subject*s predicted operative mortality or serious, irreversible morbidity risk is less than 50% at 30 days post index procedure
Exclusion criteria
Exclusion criteria: 1. Subject is unwilling or unable to comply with all study-required follow-up evaluations 2. Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (*180 days) prior to the index procedure. 3. Subject has hostile chest or other condition that complicates transapical access 4. Subject has carotid artery disease requiring intervention. 5. Evidence of a myocardial infarction (MI) within 180 days prior to patient providing consent (defined as: ST Segment elevation as evidenced on 12 Lead ECG) . 6. Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography. 7. Subject has mitral valvular regurgitation greater than grade III) 8. Subject has moderate to severe mitral stenosis. 9. Subject has aortic root angulation greater than (>)70 degrees (horizontal aorta). 10. Distance from the left ventricular apex tothe aortic annulus is less than 45mm (4.5cm). 11. Subjetcs has pre-existing prosthetic valve or prosthetic ring in any position. 12. Subject refuses blood transfusion 13. Subject refuses surgical valve replacement. 14. Subject has resting left ventricular ejection fraction (LVEF) less than 20%. 15. The subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization. 16. Subject has had a percutaneous interventional or other invasive cardiac or peripheral procedure * 14 days of the index procedure. 17. Subject has severe basal septal hypertrophy that would interfere with transcatheter valve placement. 18. Subject has a history of or has active endocarditis. 19. There is imaging evidence of intracardiac mass, thrombus, or vegetation. 20. Subject is considered hemodynamic unstable (requiring inotropic support or mechanical heart assistance). 21. Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure. 22. Subject with significant pulmonary disease as determined and documented by the Investigator. 23. Subject has significant chronic steroid use as determined and documented by the Investigator. 24. Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication. 25. Subject has renal insufficiency as evidenced by a serum creatinine > 3.0mg/dL (265.5 *mol/L) or end-stage renal disease requiring chronic dialysis. 26. Subject has morbid obesity defined as BMI * 40. 27. Subject has ongoing infection or sepsis. 28. Subject has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy). 29. Subject has a current autoimmune disease that, in the opinion of the Principal Investigator or Subject Selection Committee, precludes the subject from study participation. 30 Significant ascending aortic disease documented by diameter greater than 40mm. 31. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure. 32. Subject is currently participating in another investigational drug or device study. 33. Subject requires emergency surgery for any reason within 30 days of the index procedure. 34. Subject has a life expectancy < 12 months. 35. Subject has other medical, social or psychological conditions that, in the opinion of the Subject Selection Committee, pr
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: periprocedural encephalopathy all stroke all TIA 2. Functional improvement from baseline as compared to 30 days by: * NYHA Functional Classification * Six Minute Walk Test * Effective Orifice Area (EOA) 3. Acute device success defined as: * Ability of the Portico TA Delivery System to successfully deliver, deploy, and resheath (if necessary) a transcatheter aortic valve * Absence of procedural mortality * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Intended performance of the prosthetic heart valve (mean aortic valve gradient | — |
Countries
The Netherlands
Outcome results
None listed