NL-OMON53564招募中不适用
InvEstigation of the safety and perforMance of the NVT ALLEGRA THV System with a new delivery system in Patients with severe calcified aortIc stenosis or failed suRgical aortic bioprosthEsis - EMPIRE Study
VT GmbH0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
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
- •Inclusion Criteria:
- •Patients will be included if ALL of the following criteria are met:
- •1. Symptomatic severe calcific stenosis of a native aortic valve with an AVA
- •<=1.0 cm2 (or AVA index <=0.6 cm2/m2), AND mean aortic pressure gradient >= 40mmHg
- •OR maximal transaortic velocity >=4.0m/s OR Doppler velocity index <=0.25 on
- •site-reported echocardiography OR symptomatic patients with degeneration of a
- •surgical bioprosthetic valve (stenosis and/or insufficiency) on sitereported
- •echocardiography
- •2. Local multi-disciplinary Heart Team and Central Screening Committee (CSC)
- •agree on indication and eligibility for TAVI
- •3. Age >=18 years
- •4. Patient has signed the Patient Informed Consent Form
- •5. Patient is willing and able to comply with requirements of the study,
- •including all follow-up visits
排除标准
- •Exclusion Criteria
- •1. Mean aortic annulus diameter as measured by preprocedural CT or internal
- •diameter of the bioprosthesis is <16.5 mm or >27 mm
- •2. Echocardiographic evidence of intracardiac thrombus or vegetation
- •(site-reported)
- •3. Significant disease of the aorta that would preclude safe advancement of the
- •ALLEGRA THV System
- •4. Severe ilio-femoral vessel disease that would preclude safe placement of an
- •18 Fr introducer sheath or make endovascular access impossible
- •5. Severe tricuspid regurgitation and/or failing right heart (site-reported)
- •6. Severe left ventricular dysfunction with ejection fraction (EF) <20%
- •(site-reported)
- •7. Evidence of active endocarditis or other acute infections
- •8. Renal failure requiring continuous renal replacement therapy
- •9. Untreated clinically significant coronary artery disease requiring
- •revascularization
- •10. Any percutaneous interventional procedure (e.g. PCI with stenting) within
- •14 days prior of the index procedure
- •11. Acute MI <=30 days prior to the index procedure
- •12. Symptomatic carotid or vertebral artery disease requiring intervention or
- •carotid/vertebral intervention within the preceding 45 days
- •13. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) <=6 months
- •or prior CVA with moderate or severe disability (e.g. modified Rankin scale
- •score >2)
- •14. History of bleeding diathesis or coagulopathy; acute blood dyscrasias as
- •defined: thrombocytopenia (platelets <80,000/µl), acute anemia (hemoglobin <10
- •g/dl), leukopenia (WBC <3000/ µl)
- •15. Active peptic ulcer or gastrointestinal (GI) bleeding <=3 months
- •16. Severe (greater than 3+) mitral insufficiency (sitereported)
- •16a. Pre-existing prosthetic heart valve in any position other than aortic
- •17. Uncontrolled atrial fibrillation
- •18. Required emergency surgery for any reason
- •19. Known hypersensitivity to contrast media, which cannot be adequately
- •pre-medicated or contraindication to anticoagulant or anti-platelet medication
- •or to nitinol alloy or to bovine tissue
- •20. Life expectancy <=12 months due to other medical illness
- •21. Currently participating in another investigational drug or device study
- •22. Pregnancy or intend to become pregnant during study participation
- •Specific exclusions in patients with native aortic valve disease
- •(site-reported):
- •23. Unicuspid or bicuspid aortic valve
- •24. Non-calcified aortic stenosis
- •25. Predominant aortic regurgitation > grade 3
- •26. Distance between native aortic valve basal plane and the orifice of the
- •lowest coronary artery <8 mm
- •Specific exclusions in patients with degenerated surgical bioprosthetic aortic
- •valves (valve-in-valve) (site-reported):
- •27. Low position of the coronary ostia, especially in combination with shallow
- •sinuses (high risk of coronary occlusion)
- •28. Partially detached leaflets that may obstruct a coronary ostium
- 另有 1 项未显示
研究者
相似试验
已完成
不适用
STUDY TO EVALUATE THE SAFETY AND VIABILITY OF THE IMPLEMENTATION OF NT-503 IN THE VITTURAL CAVITY FOR THE TREATMENT OF SUBFOVEAL COROID NEOVASCULARIZATION (NVC) SECONDARY TO AGE-ASSOCIATED MACULAR DEGENERATION (DMAE)PER-163-08EUROTECH,
已完成
1 期
Evaluation of the Safety and Tolerability of the ‘LeVe CPAP Flow Generator’ in Healthy Volunteers at Mengo Hospital in Kampala UgandaRespiratoryPACTR202105734146484Mengo Hospital20
未知
不适用
The investigation of the safety and efficiency of desk work using automatic wheel chair with assistance for standing in the person with a disability of lower extremityPerson with a disability of lower extremityJPRN-UMIN000023678Tottori University Hospital10
招募中
不适用
The evaluation for safety and effectiveness of the laparoscopic radical hysterectomy and pelvic lymphadenectomy for stage IA, IB and IIA uterine cervical cancer.terine cervical cancerJPRN-UMIN000016183agoya University Graduate School of Medicine, Department of Obstetrics and Gynecology10
已完成
不适用
Application of the critical view of safety during laparoscopic cholecystectomyThe patients underwent laparoscopic cholecystectomy.laparoscopic cholecystectomycritical view of safetybile duct injurycomplicationTCTR20210705004/A1,000