NL-OMON41483已完成不适用
ASSESSMENT OF THE ST. JUDE MEDICAL PORTICO* TRANSCATHETER AORTIC VALVE IMPLANT (TAVI) AND THE SJM TAVI TRANSFEMORAL DELIVERY SYSTEM - PORTICO TF E
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
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 99（—）
入选标准
- •1. Subject has given written study Informed Consent for participation prior to
- •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 <1.0 cm2 (or aortic valve area index <= 0.6 cm2/m2).
- •(Baseline measurement taken by echo within 30 days of procedure).
- •5. Subject has symptomatic aortic stenosis as demonstrated by NYHA
- •Functional Classification of II or greater.
- •6. Subject is deemed high operable risk and suitable for TAVI per the
- •medical opinion of the Subject Selection Committee (See Section 3.1 for
- •the definition of the Subject Selection Committee).
- •7. Subject*s predicted operative mortality or serious, irreversible morbidity
- •risk is <50% at 30 days.
- •8. In the opinion of the Subject Selection Committee and based upon
- •angiographic measurements, the subject has suitable peripheral vessels
- •and aorta to allow for access of the delivery system.
- •9. Subject has structurally normal cardiac anatomy.
- •10. Subject is willing and able to comply with all required follow-up
- •evaluations.
排除标准
- •1. Subject has a history of a cerebral vascular accident (CVA) or transient
- •ischemic attack (TIA) within the past 6 months (<=180 days) of the index
- •2. Subject has carotid artery disease requiring intervention.
- •3. Subject has evidence of a myocardial infarction (MI) (defined as: ST
- •Segment elevation as evidenced on 12 Lead ECG) within the past 6
- •months (<=180 days) of the index procedure.
- •4. Subject has hypertrophic cardiomyopathy.
- •5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid,
- •quadricuspid or non-calcified as seen by echocardiography.
- •6. Subject has mitral or tricuspid valvular regurgitation (> 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
- •9. Subject refuses blood transfusion or surgical valve replacement.
- •10. Subject has resting left ventricular ejection fraction (LVEF) < 20%.
- •11. The subject has documented, untreated symptomatic coronary artery
- •disease (CAD) requiring revascularization.
- •12. Subject has severe basal septal hypertrophy.
- •13. Subject has had a percutaneous interventional or other invasive cardiac or
- •peripheral procedure <= 14 days of the index procedure.
- •14. Subject has a history of or has active endocarditis.
- •15. Subject has echocardiographic evidence of intracardiac mass, thrombus,
- •or vegetation.
- •16. Subject has hemodynamic instability (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 significant pulmonary disease as determined and
- •documented by the Investigator.
- •19. Subject has significant chronic steroid use as determined and documented
- •by the Investigator.
- •20. Subject has a known hypersensitivity or contraindication to anticoagulant
- •or antiplatelet medication.
- •21. Subject has renal insufficiency as evidenced by a serum creatinine > 3.0
- •mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic
- •22. Subject has morbid obesity defined as BMI >= 40.
- •23. Subject*s iliac arteries have severe calcification, tortuosity (>two 90 degree
- •bends), diameter <6mm, or subject has had an aorto-femoral bypass.
- •24. Subject has ongoing infection or sepsis.
- •25. Subject has blood dyscrasias (leukopenia, acute anemia,
- •thrombocytopenia, bleeding diathesis, or coagulopathy).
- •26. Subject has a current autoimmune disease that, in the opinion of the
- •Principal Investigator precludes the subject from study participation.
- •27. Subject has significant aortic disease, including:
- •o aortic abdominal aneurysm (AAA) >= 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
- 另有 6 项未显示
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