Aorta Valve Stenosis Narrowing of the heart valve
Conditions
Interventions
Subclavia/transaxillaire of transaortale (TAo) placement of the Portico
transcatheter aortavalve according to a normal TAVI procedure.
Sponsors
Abbott
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject has provided written informed consent prior to uploading CT scan to core lab. 2. Subject is 18 years of age of legal age in the host country. 3. Subject*s aortic annulus diameter meets the range indicated in the Instructions for Use as measured by multislice CT conducted within 180 days prior to the index procedure. 4. Subject has senile degenerative aortic stenosis seen by echocardiography within 90 days of index procedure as measured by one of the following: ; Mean gradient >= 40 mmHg ; Peak velocity >= 4.0 m/s ; Doppler Velocity Index 8% or documented heart team agreement >= high risk for SAVR due to frailty or co-morbidities
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 (less than or equal to 180 days) prior to the index procedure. 3. Subject has carotid artery disease requiring intervention. 4. Subject has evidence of a myocardial infarction (MI) within 30 days prior to patient index procedure. 5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography. 6. Subject has severe mitral valvular regurgitation. 7. Subject has severe mitral stenosis. 8. Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position. 9. Subject refuses any blood product transfusion. 10. Subject has resting left ventricular ejection fraction (LVEF) less than 20%. 11. Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization. 12. Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to 14 days prior to index procedure. 13. Subject has severe basal septal hypertrophy that would interfere with transcatheter aortic valve placement. 14. Subject has a history of, or is currently diagnosed with, endocarditis. 15. There is imaging evidence of intracardiac mass, thrombus, or vegetation. 16. Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance). 17. Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure. 18. Subject with severe pulmonary disease as determined by STS score. 19. Subject is on chronic oral steroid therapy. 20. Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication. 21. Subject has renal insufficiency as evidenced by a serum creatinine greater than 3.0 mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic dialysis. 22. Subject has morbid obesity defined as a BMI greater than or equal to 40. 23. Subject has ongoing infection or sepsis. 24. Subject has uncontrolled blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg/dL), thrombocytopenia (platelet count <50,000 cells/mm3,). 25. Anatomy falling outside the recommended values in the IFU, unless specifically approved by the Subject Selection Committee. 26. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure. 27. Subject is currently participating in another investigational drug or device study, unless approved by the Sponsor. 28. Subject has/had emergency surgery for any reason within 30 days of the index procedure. 29. Subject has a life expectancy less than 1 year. 30. Subject has other medical, social or psychological conditions that, in the opinion of the site Heart Team or the Subject Selection Committee, preclude the subject from study participation. 31. Subject is diagnosed with a state of dementia which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits. 32. Subject has a documented allergy to contrast media that cannot adequately be treated, nitinol alloys, porcine tissue, or bovine tissue. 33.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study will have a single primary safety endpoint of major vascular complications through 30 days, as defined by the Valve Academic Research Consortium (VARC-2) for each access arm of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints for each access arm of the study: 1. The event rates at 30 days of the following: • All-cause mortality • Cardiovascular mortality • Disabling stroke • Non-disabling stroke • Life-threatening bleeding requiring transfusion • Acute kidney injury requiring dialysis • Composite of * - Periprocedural encephalopathy * - all stroke * - all TIA 2. The event rates at 1 year of the following: • All-cause mortality • Cardiovascular mortality • Disabling stroke • Moderate and severe aortic regurgitation 3. Improvement from baseline as compared to 30 days by: • NYHA Functional Classification • Six minute walk test • Effective Orifice Area (EOA) 4. Acute device success defined as: • 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
Netherlands
Outcome results
None listed