NL-OMON42009撤回不适用
Assessment of the St. Jude Medical Portico (TM) Re-sheathable Transapical Aortic Valve System (PORTICO TA EU) - PORTICO TA E
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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
排除标准
- •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
研究者
相似试验
已完成
不适用
ASSESSMENT OF THE ST. JUDE MEDICAL PORTICO* TRANSCATHETER AORTIC VALVE IMPLANT (TAVI) AND THE SJM TAVI TRANSFEMORAL DELIVERY SYSTEMnarrowing of heart valveStenosis of Aortic valve10046973NL-OMON41483St. Jude Medical15
已完成
不适用
Portico TAVI Implant With Transfemoral Delivery SystemSymptomatic Aortic StenosisNCT01493284Abbott Medical Devices222
已完成
不适用
Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative AccessAortic Valve StenosisNCT03056573Abbott Medical Devices64
撤回
不适用
Assessment of the St. Jude Medical PorticoTM Re-sheathable Aortic Valve System - Alternative AccessSymptomatic Aortic StenosisNCT02088021Abbott Medical Devices
撤回
不适用
Assessment of St Jude Medical Portico Re-sheathable Transapical Aortic Valve SystemSevere Symptomatic Aortic StenosisNCT01742598Abbott Medical Devices