NL-OMON45758已完成不适用
MISSION-Registry: Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve Systyem in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry. - MISSION-Registry
Edwards Lifesciences SA0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject is 18 years or older
- •2. Subject is symptomatic for aortic stenosis (AS) or mixed aortic stenosis and aortic insufficiency (AS/AI) disease for which isolated surgical aortic valve replacement without concomitant procedures is indicated according to International guidelines.
- •3. Surgery starts with and is intended to be completed via a minimal invasive surgical approach. MIS is defined as a non-full sternotomy approach such as partial hemi-sternotomy, right anterior thoracotomy.
- •4. Subject has signed and dated the investigation informed consent forms prior to any study-specific procedures are performed.
- •5. Subject is geographically stable and agrees to attend follow-up assessments as specified in the protocol and informed consent.
排除标准
- •1. Subject is diagnosed with pure aortic insufficiency.
- •2. Subject requires multiple valve replacement/repair
- •3. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve.
- •4. Subject has severe ventricular dysfunction defined as LVEF < 25%.
- •5. Subject has a history of active endocarditis and/or myocarditis * 3 months before the intended treatment/scheduled surgery.
- •6. Subject has had an acute MI * 3 months before the intended treatment.
- •7. Subject had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery.
- •8. Subject is oxygen or ventilator dependent.
- •9. Subject has life expectancy < 12 months.
- •10. Female subject is pregnant or lactating.
- •11. Subject with documented leukopenia (WBC < 3.5x 103/*L), acute anemia (Hb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy.
- •12. Subject has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 1 month of procedure.
- •13. Subject has documented echocardiographic evidence of intracardiac mass, thrombus or vegetation.
- •14. Subject has renal insufficiency as determined by Serum creatinine * 200 *mol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis.
- •15. Subject with documented hyperparathyroidism.
- •16. Subject is currently participating in an investigational drug or device trial for which follow-up has not yet been completed.
- •17. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition.
- •18. Aneurysm of the aortic root and/or ascending aorta;Intra-operative exclusion criteria:
- •1. Subject has Type 0 congenital true bicuspid aortic valve (i.e. absence of raphe and commissures are positioned about 180 degrees apart) or unicuspid aortic valve. (A non-congenital bicuspid valve without a distorted annulus would not be cause for exclusion.)
- •2. Subject has calcium on the anterior mitral leaflet which cannot be removed.
- •3. Subject has extensive calcification of the aortic root.
- •4. Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus.
- •5. The position of the coronary ostia relative to the EDWARDS INTUITY Elite Aortic Valve could result in obstruction of blood flow.
- •6. Minimally Invasive access to the heart is not possible due to anatomical constraints or any other condition (including patient switched to a full sternotomy approach).
- •7. The device is not available in the correct size for the subject.
研究者
相似试验
已完成
不适用
The Registry to Observe Clinical Outcomes of Patients with High-risk Metastatic Hormone-naive Prostate Cancer in JapaHigh-risk metastatic hormone-naive prostate cancerJPRN-UMIN000037127Janssen Pharmaceutical K.K.102
已完成
不适用
Registry of Treatment Outcomes in a non-study population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated with Radium-223 (ROTOR-registry).bone metastases10038588Prostate cancerNL-OMON55579Antoni van Leeuwenhoek Ziekenhuis100
招募中
不适用
Registry of Treatment Outcomes in a non-study population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated with Radium-223 (ROTOR-registry)Radium-223prostate cancerNL-OMON19873etherlands Cancer Institute-Antoni van Leeuwenhoek hospital300
招募中
不适用
ationwide registration and clinical evaluation of the heavy particle beam therapy studies.Head and Neck Lung Esophagus Lower gastrointestinal tract Hepato-biliary-pancreatic Urinary organ mammary-uterine-cervix Bone and Soft tissue Metastatic diseaseJPRN-UMIN000024709ational Institutes for Quantum and Radiological Science and Technology30,000
暂停
不适用
A clinical registry to monitor outcomes of shoulder and elbow pathologyShoulder arthritisElbow arthritisShoulder dislocation/recurrent instabilityShoulder rotator cuff pathologyClavicle/humerus/scapula fractureAcromioclavicular dislocation/instabilityElbow traumaShoulder arthroplasty complication/revision/failureElbow tendon pathologyMusculoskeletal - OsteoarthritisInjuries and Accidents - FracturesMusculoskeletal - Other muscular and skeletal disordersACTRN12617000864325Mr Harry Clitherow15,000