KCT0003085终止未知
Transcatheter Aortic Valve Replacement for Pure Severe Aortic Regurgitation, Pilot study
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Patients must have co-morbidities such that the principal investigator and co-investigator concur that the predicted risk of operative mortality is =15% (STS score =10 OR Logistic EuroSCORE =20%).
- •A candidate who does not meet [the STS score criteria = 10 OR Logistic EuroSCORE =20%] can be included in the study if a peer review by at least two investigators concluded and documented that the patient’s predicted risk of operative mortality is =15% from old age, severe frailty or STS score =8 . In this case, all evidence must be documented in the study case report form as well as in the patient medical record.
- •2. There is a formal agreement for transcatheter aortic valve replacement by a cardiac surgeon, echo part cardiologist and interventional cardiologist according to relevant guideline.
- •3. The subject does not have severe degenerative aortic stenosis and do have severe aortic regurgitation.
- •4. The subject or the subject’s legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- •5. The subject agrees that the subject will keep in touch with study team for all required post-procedures like angiography or transesophageal echography.
- •6. The subject agrees that the subject will cooperate with study team for all required post-procedure visits.
- •7. The subject’s age is 20 or more.
排除标准
- •1. Evidence of an acute myocardial infarction = 1 month before the intended treatment(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB = twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition).
- •2. Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent implantation).
- •3. Blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg%), thrombocytopenia (platelet count <50,000 cells/mm³), history of bleeding diathesis or coagulopathy.
- •4. Untreated clinically significant coronary artery disease requiring revascularization.
- •5. Need for emergency surgery for any reason.
- •6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- •7. Active bacterial endocarditis or other active infections.
- •8. Active peptic ulcer or upper GI bleeding within the prior 3 months.
- •9. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately pre medicated.
- •10. Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA).
- •11. Life expectancy < 12 months due to non-cardiac comorbid conditions.
- •12. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend or angle of aortic arch =200 degree),aortic arch atheroma (especially if thick [> 5mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe unfolding” and tortuosity of the thoracic aorta (applicable for transfemoral patients only).
- •13. Root disease including annuloaortic ectasia or aneurysm of root or sinus.
- •14. Iliofemoral vessel characteristics that would preclude safe placement of introducer sheath such as severe obstructive calcification, severe tortuosity(with moderate or severe calcification and two or more severe curve (angle =90°) (applicable for transfemoral patients only).
- •15. Pregnant(positive result from pregnancy test conducted during screening visit and within prior 2 weeks of valve replacement) or lactating women.
研究者
相似试验
招募中
不适用
Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve ReplacementNL-OMON53079Medtronic B.V.60
招募中
不适用
Surgical Replacement and Transcatheter Aortic Valve Implantation Trial 10 Year Follow-upsevere aortic valve stenosis10046973NL-OMON45149Medtronic B.V.160
招募中
3 期
Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR-UNLOAD)aorta stenosemoderate aortic stenosis10019280heart failureNL-OMON54518Cardiovascular Research Foundation (CRF)56
招募中
不适用
International Transcatheter Aortic Valve Replacement Registry : Multicenter observational study (Helsinki and Kamakura)aortic stenosisJPRN-UMIN000040413Shonan Kamakura General Hospital4,500
已完成
不适用
Transcatheter aortic valve replacement for patients with aortic valve stenosisSevere aortic valve stenosisJPRN-UMIN000009224Kurashiki Central Hospital Department of Cardiology Department of Cardiovascular Surgery20