CTRI/2024/05/067405尚未招募1 期
Safety and performance of a novel transcatheter treatment for symptomatic aortic stenosis by aortic pressure recovery - Nil
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
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
入选标准
- •1.Assessment and approval by site investigator and sponsor assignee, that patient is eligible candidate for this treatment and study.
- •2. The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by
- •the applicable Medical Ethics Committee (EC).
- •3. Greater than 18 years of age
- •4. Aortic sinotubular junction (STJ) diameter meets the range of 25 to 32 mm, as measured by CT (performed within the past 180 days).
- •5. Aortic brachiocephalic diameter meets the range of 27 to 35 mm, as measured by CT (performed within the past 180 days).
- •6. Patient has severe degenerative aortic stenosis with echocardiography derived mean gradient >40mmHg, and/or peak velocity greater than
- •4.0 m/s, and/or an initial valve area of <1.0 cm2
- •7.Patient has symptomatic aortic stenosis as demonstrated by NYHA of II or greater.
- •8. Patient is within the acceptable surgical risk aortic valve replacement, as assessed by the site investigator and sponsor assignee.
- •9. Patient has structurally normal cardiac anatomy.
- •10. Willing and able to comply with all required follow-up evaluation
排除标准
- •1. Patient has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 12 months.
- •2. Patient has carotid artery disease requiring intervention.
- •3. Patient has evidence of a myocardial infarction (MI) within the past 3 months.
- •4. Patient has hypertrophic cardiomyopathy, based on physician discretion.
- •5. Patient has a native aortic valve with an abnormal, or eccentric jet, as assessed by echo.
- •6. Patient has mitral or tricuspid valvular regurgitation of grade III or moderate mitral stenosis, as assessed by echo.
- •7. Patient has aortic regurgitation more than mild.
- •8. Patient has rheumatic heart disease
- •9. Patient had prior CABG operation with ascending aorta grafts.
- •10. Patient has a pre-existing prosthetic valve or prosthetic ring in any position.
- •11. Patient refuses blood transfusion or surgical valve replacement.
- •12. Patient has resting left ventricular ejection fraction (LVEF) less than 30%.
- •13. Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
- •14. Patient has severe basal septal hypertrophy, as asses by echo or CT.
- •15. Patient has had a percutaneous interventional or other invasive cardiac or peripheral procedure = 90 days of the index procedure (does not apply to diagnostic angiography or angio-CT).
- •16. Patient has a history of or has active endocarditis.
- •17. Patient has echocardiographic evidence of intra-cardiac mass, thrombus, or vegetation.
- •18. Patient has hemodynamic instability (requiring inotropic support or mechanical heart assistance).
- •19. Patient is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
- •20. Patient with significant pulmonary disease
- •21. Patient has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
- •22. Patient has renal insufficiency as evidenced by a GFR less than 30 ml per min or end-stage renal disease requiring chronic dialysis.
- •23. Patient’s iliofemoral arteries have severe calcification, tortuosity more than two 90-degree bends, diameter more than 6mm, or subject has had an aorto femoral bypass that preclude safe placement of a 18 French sheath;
- •24. Patient has blood dyscrasia (leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy).
- •25. Patient has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation.
- •26. Patient with heavily calcified aorta.
- •27. Patient has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the iliofemoral arteries.
- •28. Patient has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to procedure.
- •29. Patient has a life expectancy of less than 12 months.
- •30. Patient has other medical, social or psychological conditions that, in the opinion of the Principal Investigator, preclude the subject from study participation.
- •31. Patient has a known allergy to contrast media or niti
研究者
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