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Evaluation of the Performance, Efficacy and Safety of Transapical Aortic Valve Implantation of the J?ValveTM System in Patients with Severe Symptomatic Native Aortic Valve Stenosis and/or Regurgitation with Elevated Surgical Risk
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注册号:

Registration number:

ChiCTR-OPC-15006354 

最近更新日期:

Date of Last Refreshed on:

2015-05-06 

注册时间:

Date of Registration:

2015-01-15 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

评估介入人工生物心脏瓣膜及其植入系统在高手术风险的严重主动脉瓣狭窄及/或关闭不全患者中的有效性和安全性 

Public title:

Evaluation of the Performance, Efficacy and Safety of Transapical Aortic Valve Implantation of the J?ValveTM System in Patients with Severe Symptomatic Native Aortic Valve Stenosis and/or Regurgitation with Elevated Surgical Risk 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

评估介入人工生物心脏瓣膜及其植入系统在高手术风险的严重主动脉瓣狭窄及/或关闭不全患者中的有效性和安全性 

Scientific title:

Evaluation of the Performance, Efficacy and Safety of Transapical Aortic Valve Implantation of the J?ValveTM System in Patients with Severe Symptomatic Native Aortic Valve Stenosis and/or Regurgitation with Elevated Surgical Risk 

研究课题代号(代码):

Study subject ID:

S20131216 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

朱达 

研究负责人:

石应康 

Applicant:

Zhu Da 

Study leader:

Shi Yingkang 

申请注册联系人电话:

Applicant telephone:

+86 18628321330 

研究负责人电话:

Study leader's telephone:

+86 18980601001 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

250794259@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

drguoyq@qq.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

中国成都市国学巷37号 

研究负责人通讯地址:

中国成都市国学巷37号 

Applicant address:

37 GuoXueXiang, Chengdu, Sichuan, China 

Study leader's address:

37 GuoXueXiang, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610041 

研究负责人邮政编码:

Study leader's postcode:

610041 

申请人所在单位:

四川大学华西医院 

Applicant's institution:

West China Hospital, Sichuan University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2014年临床试验(器械)审(6)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

四川大学华西医院临床试验与生物医学伦理专委会审查批件 

Name of the ethic committee:

Ethic committee of West China Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-03-19 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

四川大学华西医院 

Primary sponsor:

West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

中国成都市国学巷37号 

Primary sponsor's address:

37 GuoXueXiang, Chengdu, Sichuan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西医院

具体地址:

中国成都市国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 GuoXueXiang, Chengdu, Sichuan, China

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

阜外心血管病医院

具体地址:

北京阜成路

Institution
hospital:

Fuwai hospital

Address:

Fucheng Road

经费或物资来源:

苏州杰成医疗科技有限公司 

Source(s) of funding:

JieCheng Medical Technoligies inc 

研究疾病:

严重主动脉瓣狭窄及/或关闭不全 

Target disease:

Severe Aortic Valve Stenosis and/or Regurgitation 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

III期临床试验 

Study phase:

研究目的:

评估介入人工生物心脏瓣膜及其植入系统在高手术风险的严重主动脉瓣狭窄及/或关闭不全患者中的有效性和安全性 

Objectives of Study:

Evaluation of the Performance, Efficacy and Safety of Transapical Aortic Valve Implantation of the J?ValveTM System in Patients with Severe Symptomatic Native Aortic Valve Stenosis and/or Regurgitation with Elevated Surgical Risk 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

CI1. 签署书面的知情同意书 CI2. 年龄≥18岁 CI3. 表现有因主动脉瓣狭窄或/和关闭不全导致的病症,且纽约心脏病协会心功能分级NYHA≥ II CI4. 经至少一位心脏介入医生和两位心血管外科医生诊断:受试者对于传统开胸换瓣术禁忌【定义为术后30天内死亡风险>50%或存在严重不可逆合并症或其他影响手术的因素(如升主动脉和主动脉瓣严重钙化、体质脆弱、胸部畸形、严重肝脏疾病,严重肺部疾病等)】或外科手术高危(LogEuroSCORE≥20%与/或STS≥8) CI5. 经至少一位心脏介入医生和两位心血管外科医生认为,植入瓣膜可能使患者受益; CI6. 严重主动脉瓣狭窄或/和关闭不全,超声心动图结果表明:平均跨瓣压力阶差≥40 mm Hg,或主动脉前向血流峰流速≥4.0 m/s,或主动脉瓣瓣口面积< 0.8 cm2(或AVA 指数< 0.5 cm2/m2),有症状的中度返流或重度返流; CI7. 无严重肺动脉高压; CI8. 受试者同意配合所有的随访检查。 入选的解剖学标准: AI1. 主动脉瓣环直径>19毫米和<29毫米,以心脏CT测量为准; AI2. 升主动脉直径<50毫米,以窦管交界直径为准。 

Inclusion criteria

CI1. Sign the letter of consent; CI2. Age >=18-years; CI3. Shows disease caused by aortic stenosis and/or regurgitation, with NYHA>=II; CI4. At least one cardiovascular specialist and two cardiovascular surgeons diagnose that: subjects are tabooed with traditional opening heart valve replacement surgery (which is defined as the risk of death during 30days after surgery is more than 50% or existing severe irreversible complications or other factors affecting the surgery (such as ascending aorta and severe aortic valve calcification, fragile physique, chest deformity, severe liver disease, severe lung disease, etc.)) or high-risk surgery (LogEuroSCORE≥20% and/or STS≥8); CI5. At least one cardiovascular specialist and two cardiovascular surgeons believe that the patient will benefit from valve implantation. CI6. Severe aortic stenosis and/or regurgitation, echocardiography results showing average pressure >=40 mm Hg, or aortic blood flow peak flow >=4.0 m/s, or aortic prosthetic valve area <0.8 cm2 (or AVA index <0.5 cm2/m2). Or/and Moderate aortic insufficiency with clinical symptom or severe aortic insufficiency patients; CI7. No severe pulmonary hypertension; CI8. Participant agrees with all follow-up tests; Anatomical inclusion criteria: AI1. Aortic valve ring diameter >19 mm and <29 mm, confirmed by CT measurement; AI 2 Ascending aortic diameter <43 mm in diameter, as referenced with the sinotubular junction. 

排除标准:

CE1. 感染患者或疑似感染 CE2. 既往心内膜炎史或活动性心内膜炎者 CE3. 30天内曾发生急性心肌梗死(Q波MI,或非Q波MI伴有肌酸激酶同工酶,肌钙蛋白T升高) CE4. 超声心动图发现任何心内团块、左心室或心房血栓、赘生物 CE5. 患有不受控制的房颤 CE6. 家族性肥厚型心肌病 CE7. 二尖瓣或三尖瓣瓣膜功能不全(返流Ⅱ级以上) CE8. 之前接受过主动脉瓣移植物(机械瓣或生物瓣支架) CE9. 已知对造影剂、阿司匹林、肝素、噻氯匹定类药物、镍钛记忆合金或猪产品过敏; CE10. 已知对所有的抗凝方案禁忌或过敏,或在试验过程中无法使用抗凝剂 CE11. 已知有以下之一情况者(根据从筛查时至手术当天的评估) a) 可能会使预期寿命缩减至小于12个月的其他严重疾病(如临床有复发或转移的癌症、充血性心力衰竭等) b) 目前有药物滥用问题(如酒精、可卡因、海洛因等) c) 计划接受可能会引起方案不依从或数据理解混淆的手术。 CE12. 过去6个月内有脑血管意外(CVA) CE13. 颈总或颈内动脉或椎动脉狭窄(> 70%)的患者 CE14. 白细胞计数<3×109/L,血小板计数<50×109/L; CE15. 血红蛋白<90 g/L;Hb <90 g / L CE16. 严重左室功能低下,左室射血分数< 20 % CE17. 腹腔或胸腔主动脉瘤; CE18. 肝性脑病或急性活动性肝炎; CE19. 正在接受透析或基线肌酐水平>2.5 mg/dL(221μmoI/L) CE20. 有出血倾向或凝血疾病史或拒绝输血 CE21. 有活动性胃溃疡或活动性胃肠(GI)出血; CE22. 患有严重影响行动能力、日常生活能力的神经系统疾病; CE23. 严重痴呆者 CE24. 任何原因需要紧急手术; CE25. 正在参加其他研究药物或器械的临床研究; CE26. 有妊娠或计划怀孕者,或正在服用雌激素或类雌激素药物的患者(怀疑怀孕的女性在纳入研究前,人绒毛促性腺激素的血清或尿液测试必须为阴性) 

Exclusion criteria:

CE1. Infected patients or suspected infected persons; CE2. Past history of or active endocarditis endocarditis; CE3. Acute myocarditis within the past 30 days. (Q-wave MI, or non-Q-wave MI associated with creatine kinase isoenzyme, troponin T rise); CE4. Any cardiac mass, left ventricular or atrial thrombus found by echocardiogram; CE5. Uncontrolled atrial fibrillation; CE6. Familial hypertrophic cardiomyopathy; CE7. Mitral or tricuspid valvular insufficiency (regurgitation greater then II); CE8. Previously undergone aortic graft (mechanical valve or biological valve stent); CE9. Known allergy for contrast agents, aspirin, heparin, ticlopidine, nitinol or porcine products; CE10. Known contraindication or allergies to anti-coagulants, or if anti-coagulants are unable to be used during the study; CE11. Any participants with the following conditions (from the time of screening to the day of surgery): a) Other diseases that may reduce life expectancy to less than 12 months (cancer, congestive heart failure, etc.); b) Drug abuse (alcohol, cocaine, heroin, etc.); c) Plans to undergo surgery that may result in non-compliance with the study or cause confusion in data interpretation; CE12. Cerebrovascular accident (CVA) within the past six months; CE13. Suffering from symptomatic carotid or vertebral artery stenosis (>70%) of the patients. CE14. Leukocyte count <3*10^9/L, platelet count <50*10^9/L; CE15. Hb <90g/L; CE16. Severe ventricular dysfunction, left ventricular ejection fraction <20%; CE17. Abdominal or thoracic aortic aneurysm; CE18. Hepatic encephalopathy or acute active hepatitis; CE19. Undergoing dialysis or baseline creatinine level>2.5 mg/dL (221μmoI/L); CE20. Has a history of bleeding tendencies or clotting disorders or refuses blood transfusions. CE21. Active ulcer or gastrointestinal (GI) bleeding; CE22. Severe neurological disorders affecting daily life CE23. Severe dementia; CE24. Any reason needs emergency operation; CE25. Taking part in clinical research studies of drugs or other devices; CE26. Pregnant or planning pregnancy or patients taking estrogen or estrogen-like drugs (enrolled patients who may be pregnant suspected of pregnant women must test negative for serum and urine human chorionic gonadotropin). 

研究实施时间:

Study execute time:

From2014-03-20To  

干预措施:

Interventions:

组别:

单组队列研究

样本量:

100

Group:

Single cohort

Sample size:

干预措施:

使用介入人工心脏瓣膜

干预措施代码:

Intervention:

Using J-Valve system

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西医院 

单位级别:

三甲医院 

Institution
hospital:

West china hospital, Sichuan University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

阜外心血管病医院 

单位级别:

三甲医院 

Institution
hospital:

Fuwai hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

复旦大学附属中山医院 

单位级别:

三甲医院 

Institution
hospital:

Zhongshan hospital of Fudan university  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

全因死亡率

指标类型:

主要指标 

Outcome:

All cause mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心血管病死亡率

指标类型:

主要指标 

Outcome:

Cardiovascular related mortality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

介入人工心脏瓣膜植入后功能

指标类型:

主要指标 

Outcome:

Function of J-Valve after implantation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

介入人工瓣膜相关并发症

指标类型:

主要指标 

Outcome:

J-Valve related complication

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 50 years
最大 Max age 95 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

NA

Randomization Procedure (please state who generates the random number sequence and by what method):

NA

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-01-15
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