中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2300075396
最近更新日期： Date of Last Refreshed on：	2024-02-01 21:08:04
注册时间： Date of Registration：	2023-09-04 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	PulveClip经导管二尖瓣夹及输送系统治疗慢性中重度或重度二尖瓣反流的临床研究
Public title：	Clinical study of the PulveClip transcatheter mitral clip and delivery system for the treatment of chronic moderate-to-severe or severe mitral regurgitation
注册题目简写：
English Acronym：
研究课题的正式科学名称：	PulveClip经导管二尖瓣夹及输送系统治疗慢性中重度或重度二尖瓣反流的临床研究
Scientific title：	Clinical study of the PulveClip transcatheter mitral clip and delivery system for the treatment of chronic moderate-to-severe or severe mitral regurgitation
研究课题代号(代码)： Study subject ID：
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：	王文文	研究负责人：	董念国
Applicant：	Wenwen Wang	Study leader：	Nianguo Dong
申请注册联系人电话： Applicant telephone：	+86 870798290	研究负责人电话： Study leader's telephone：	+86 139 7118 1551
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：	wangww@pushmedical.com	研究负责人电子邮件： Study leader's E-mail：	dongnianguo@hotmail.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：	上海市嘉定区城北路1355号A栋927	研究负责人通讯地址：	湖北省武汉市江汉区解放大道1277号
Applicant address：	927, Building A, 1355 Chengbei Road, Jiading District, Shanghai, China	Study leader's address：	1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	上海普实医疗器械股份有限公司
Applicant's institution：	Shanghai Push Medical Equipment Co. LTD
研究负责人所在单位：	华中科技大学同济医学院附属协和医院
Affiliation of the Leader：	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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：	[2023]伦审字(0330)号	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	华中科技大学同济医学院附属协和医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
伦理委员会批准日期： Date of approved by ethic committee：	2023-05-09 00:00:00
伦理委员会联系人：	褚圆圆
Contact Name of the ethic committee：	Chu Yuanyuan
伦理委员会联系地址：	湖北省武汉市江汉区解放大道1277号7栋402
Contact Address of the ethic committee：	402, Building 7, 1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 27 8572 6375	伦理委员会联系人邮箱： Contact email of the ethic committee：	whunionlunli@126.com

研究实施负责（组长）单位：

华中科技大学同济医学院附属协和医院

Primary sponsor：

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

研究实施负责（组长）单位地址：

湖北省武汉市江汉区解放大道1277号

Primary sponsor's address：

1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, 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)：	湖北	市(区县)：	武汉
Country：	China	Province：	Hubei	City：	Wuhan
单位(医院)：	华中科技大学同济医学院附属协和医院	具体地址：	湖北省武汉市江汉区解放大道1277号
Institution hospital：	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Address：	1277 Jiefang Avenue, Jianghan District, Wuhan, Hubei, China

经费或物资来源：

上海普实医疗器械股份有限公司

Source(s) of funding：

Shanghai Push Medical Equipment Co. LTD

研究疾病：

二尖瓣反流

Target disease：

mitral regurgitation

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

I期临床试验

Study phase：

1

研究设计：

单臂

Study design：

Single arm

研究目的：

评价上海普实医疗器械股份有限公司研发的PulveClip经导管二尖瓣夹及输送系统在在慢性中重度（3+）和重度（4+）二尖瓣反流且经当地临床试验机构心脏团队评估为外科手术高危的患者中的有效性和安全性。

Objectives of Study：

To evaluate the efficacy and safety of the PulveClip transcatheter mitral clip and delivery system developed by Shanghai Pusi Medical Devices Co., Ltd. in patients with chronic moderate-to-severe (3+) and severe (4+) mitral regurgitation evaluated as high risk for surgical procedures by the cardiac teams of local clinical trial organizations.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Patients aged >= 18 years of age;
2. Patients with clinical symptoms and echocardiographically confirmed moderate-severe (3+) or severe (4+) chronic mitral regurgitation (MR) (including DMR and FMR1);
3. NYHA cardiac function class II-IV;
4. Left ventricular ejection fraction LVEF >= 20%;
5. Anatomically suitable for mitral valve valve repair and evaluated for suitability for use of the study device;
6. If the patient is a DMR it is required to fulfill:
(1) Tendon cable rupture resulting in prolapse;
(2) Surgical high risk as judged by the local clinical trial site cardiac team, with the recommended reference criteria being a surgical valve replacement STS score of >= 8 or a surgical valve repair STS score of >= 6 or the presence of other surgical high risk factors (e.g., the presence of >= 2 indicators of moderate-to-severe weakness or the presence of possible impaired surgical maneuvers or the presence of >= 2 major organ dysfunction that does not improve in the postoperative period or other surgical high risk factors judged by the cardiac team to determine the presence of other surgical risk factors);
To be met if the patient is FMR:
(1) Symptomatic functional mitral regurgitation FMR (>= 3+) due to ischemia or non-ischemic cardiomyopathy;
(2) Left ventricular end-systolic internal diameter (LVESD) <= 70 mm;
(3) At least one hospitalization for heart failure in the past 12 months and/or subject has a BNP > 150 pg/ml,or corrected2 NT-proBNP > 600 pg/ml;
(4) Obtained after stabilization on optimal therapy including Guideline Directed Medical Therapy (GDMT) therapy or after at least 30 days of the following: GDMT dose increase greater than 100% or decrease greater than 50%; coronary revascularization and or implantation of a cardiac resynchronization therapy device (CRT or CRT-D), or reprogramming of an implanted CRT or CRT-D to increase biventricular pacing (from < 92% to >= 92%).
(5) Moderate-to-severe (3+) or greater regurgitation remains after GDMT;
7. Subjects have been informed of the nature of the study, are able to understand the purpose of the clinical trial, and voluntarily participate and sign an informed consent form.
Note 1: FMR requires the presence of global or localized LV wall motion abnormalities that are considered to be the primary cause of MR. Subjects are not eligible if leaflet prolapse or other evidence of degenerative MR is present, even if there is overall or localized LV systolic dysfunction.
Note 2: Correction is when the patient's body mass index BMI is above 20 kg/m2, and for every lkg/m2 increase in BMI, the NT-proBNP cutoff is reduced by 4%.

排除标准：

1.超声心动图提示有心内肿块、血栓或赘生物存在； 2.存在其他需要手术干预的严重心脏瓣膜病； 3.二尖瓣外科手术术后或二尖瓣经导管手术术后； 4.中重度右心功能不全，或肺动脉收缩压升高（超声心动图测得肺动脉收缩压PASP>70mmHg)； 5.4周内发生过急性心肌梗死； 6.30天内行过任何心血管介入手术；或6个月内行过心脏外科手术；或注册前30天内行过心脏起搏器治疗或心脏再同步化治疗(CRT、CRT-D)或埋藏式心律转复除颤器(ICD)植入治疗； 7.存在全身麻醉禁忌； 8.终末期心力衰竭(ACC/AHA D期），或心脏移植术后或等待心脏移植； 9.活动性心内膜炎或活动性风湿性心脏病或因心内膜炎、风湿性心脏瓣膜病导致的二尖瓣瓣叶改变（如顺应性差、穿孔等），或引起菌血症的其他感染； 10.30天内脑血管意外史，或重度症状性颈动脉狭窄（超声检查显示狭窄程度>70%)；或30天内进行过颈动脉支架植入术； 11.消化性溃疡或消化道出血急性期； 12.出血性疾病或凝血障碍性疾病；或存在抗血栓药物治疗禁忌； 13.改良Rankin量表评分≥4分； 14.所患疾病会造成治疗的评价困难（如癌症、严重代谢性疾病、精神病等）； 15.血流动力学不稳定，定义为不使用后负荷降低药物时收缩压＜90mmHg,或心源性休克；或需要血管活性药物治疗；或需要主动脉内球囊搏；或其他血流动力学支持装置； 16.肥厚型心肌病伴或不伴梗阻者，限制性心肌病，缩窄性心包炎，浸润性心肌病（如淀粉样变性、血色病、肉芽肿等），或除外扩张型心肌病的其他导致心衰的结构性心脏病； 17.受试者目前正在参与一项尚未完成主要终点或会在临床上干扰本研究终点的试验性药物或其他器械研究； 18.研究者判断患者依从性差，无法按照要求完成研究；或研究人员认为受试者不适合参加该研究的其他情形。

Exclusion criteria：

1. The presence of an intracardiac mass, thrombus, or redundant organism as suggested by echocardiography; 2. Presence of other severe heart valve disease requiring surgical intervention; 3. Postoperative mitral valve surgery or postoperative transcatheter mitral valve surgery; 4. Moderate to severe right heart insufficiency, or elevated pulmonary artery systolic pressure (pulmonary artery systolic pressure PASP > 70 mmHg measured by echocardiography); 5. Acute myocardial infarction within 4 weeks; 6. Any cardiovascular intervention within 30 days; or cardiac surgery within 6 months; or pacemaker therapy or cardiac resynchronization therapy (CRT, CRT-D) or implantation of an implantable cardioverter defibrillator (ICD) within 30 days prior to registration; 7. Presence of contraindications to general anesthesia; 8. End-stage heart failure (ACC/AHA stage D), or after or awaiting heart transplantation; 9. Active endocarditis or active rheumatic heart disease or changes in the mitral valve leaflets (e.g., poor compliance, perforation, etc.) due to endocarditis, rheumatic heart valve disease, or other infections causing bacteremia; 10. History of cerebrovascular accident within 30 days, or severe symptomatic carotid artery stenosis (>70% stenosis on ultrasound); or carotid stenting within 30 days; 11. Peptic ulcer or acute stage of gastrointestinal bleeding; 12. Bleeding disorders or coagulopathies; or contraindication to antithrombotic drug therapy; 13. Modified Rankin Scale score >= 4; 14. Diseases that would make evaluation of treatment difficult (e.g., cancer, severe metabolic diseases, psychiatric disorders, etc.); 15. Hemodynamic instability, defined as a systolic blood pressure < 90 mmHg without afterload-lowering medications, or cardiogenic shock; or the need for vasoactive drug therapy; or the need for intra-aortic balloon pacing; or other hemodynamic support devices; 16. Hypertrophic cardiomyopathy with or without obstruction, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis, etc.), or other structural heart disease leading to heart failure other than dilated cardiomyopathy; 17. The subject is currently participating in an experimental drug or other device study that has not completed the primary endpoint or would clinically interfere with the endpoints of this study; 18. In the judgment of the investigator, the patient has poor compliance and is unable to complete the study as required; or other circumstances that, in the opinion of the investigator, make the subject unsuitable for participation in the study.

研究实施时间：

Study execute time：

从 From 2023-05-01 00:00:00至 To 2023-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-09-16 00:00:00 至 To 2023-12-31 00:00:00

干预措施：

Interventions：

组别：	实验组	样本量：	10
Group：	experimental	Sample size：	10
干预措施：	使用PulveClip经导管二尖瓣夹及输送系统做二尖瓣夹合术	干预措施代码：
Intervention：	Mitral Clamping with the PulveClip Transcatheter Mitral Clamp and Delivery System	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	湖北	市(区县)：	武汉
Country：	China	Province：	Hubei	City：	Wuhan
单位(医院)：	华中科技大学同济医学院附属协和医院	单位级别：	三甲
Institution hospital：	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	术后即刻器械植入成功率	指标类型：	主要指标
Outcome：	Immediate postoperative device implantation success rate	Type：	Primary indicator
测量时间点：	术后即刻	测量方法：
Measure time point of outcome：	Immediately after surgery	Measure method：

指标中文名：	即刻手术成功率	指标类型：	次要指标
Outcome：	Immediate Surgical Success Rate	Type：	Secondary indicator
测量时间点：	术后即刻	测量方法：
Measure time point of outcome：	Immediately after surgery	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	18	岁 years
最大 Max age	100	岁 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	无
Blinding：	None

是否共享原始数据： IPD sharing	否No
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）：	否/No
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	/No
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：	否/No
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	/No
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2023-09-04 11:38:29