ChiCTR-TRC-12002577 版本V1.1 版本创建时间2015/10/30 20:10:44 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR-TRC-12002577 

最近更新日期：

Date of Last Refreshed on：

 2015-10-30 19:49:41 

注册时间：

Date of Registration：

 2012-10-19 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Public title：

Cardiac Contractility Modulation for the Treatment of Heart Failure – Impact of Haemodynamic Optimization of Lead Position

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

Cardiac Contractility Modulation for the Treatment of Heart Failure – Impact of Haemodynamic Optimization of Lead Position

研究课题代号(代码)：

Study subject ID：

 CRE-2004.294-T

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：

 

研究负责人：

 

Applicant：

Ms Sheung Poon 

Study leader：

Prof. CM Yu 

申请注册联系人电话：

Applicant telephone：

 +852 2632 1752

研究负责人电话：

Study leader's
telephone：

+852 2632 1752

申请注册联系人传真 ：

Applicant Fax：

 +852 2632 4755

研究负责人传真：

Study leader's fax：

 +852 2632 4755

申请注册联系人电子邮件：

Applicant E-mail：

 poonsps@yahoo.com.hk

研究负责人电子邮件：

Study leader's E-mail：

 cmyu@cuhk.edu.hk

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：

研究负责人通讯地址：

Applicant address：

Room12A28, 12/F, Main Building, Prince of Wales Hospital, Shatin, NT, HK

Study leader's address：

Room12A28, 12/F, Main Building, Prince of Wales Hospital, Shatin, NT, HK

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：

Applicant's institution：

Department of Medicine & Therapeutics

研究负责人所在单位：

Affiliation of the Leader：

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：

 CRE-2004.294-T

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：

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2004-09-07 00:00:00

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：

Primary sponsor：

Impulse Dynamics

研究实施负责（组长）单位地址：

Primary sponsor's address：

Impulse Dynanics (USA) Inc, 30 Ramland Road, Suite 103, Orangebury, NY 10962

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

CUHK

具体地址：

CUHK

Institution
hospital：

CUHK

Address：

CUHK

经费或物资来源：

Source(s) of funding：

Nil

研究疾病：

 

Target disease：

Heart Failure

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

 

Objectives of Study：

80 patients with HF who fulfill the inclusion criteria will be enrolled. Baseline clinical & echocardiographic parameters will be assessed. They will be randomized into either CCM or CCM + haemodynamic optimization of lead position (CCM + haemodynamic arm) at a ratio of 1:1. They will be followed up at pre-determined time-points where assessment will be repeated, i.e. 1 week, 1 month, 3 months and 6 months (Appendix I). Afterwards, patient will continue with long-term follow up and assessment.

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. Heart failure (HF) patients with New York Heart Association Class III or IV and EF <=40%;
2. Have been treated with optimal anti-HF medications with doses not varying by more than 50% for a minimum of 4 weeks, e.g. diuretics, Angiotensin Converting Enzyme Inhibitors or Angiotensin Receptor Blocker, beta-blockers, etc.;
3. QRS duration < 130ms or if QRS > 130ms, deemed not a candidate of cardiac resynchronization therapy by in-charge physicians;
4. If clinically indicated, patient has automatic implantable cardiac defibrillator (ICD) and/or cardiac pacemaker; if patient has a clinical indication for such device(s) but is not already implanted, patient may be enrolled if simultaneous implantation of the appropriate device is scheduled.

排除标准：

Exclusion criteria：

1. Subjects with severe symptomatic heart failure who would qualify for heart transplant, who have recently (within 3 months) been treated with intravenous inotropic agents or whose baseline VO2,max is known to be < 9 ml O2/min/kg;
2. Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease;
3. Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation;
4. Subjects who have been hospitalized for heart failure which required the use of intravenous diuretics or inotropic support within two weeks of enrollment;
5. Subjects without an ICD who have a documented history of sustained VT, or who have an indication for an ICD and are not scheduled for ICD implantation at the time of OPTIMIZER III implantation;
6. Subjects who have an ICD who have had appropriate ICD firing during the past one month;
7. Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring;
8. Subjects who have chronic atrial fibrillation or chronic atrial flutter;
9. Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions);
10. Subjects who are unable to participate in a 6-minute walk;
11. Subjects who are scheduled for a CABG or a PTCA procedure, or who have undergone a CABG procedure within three months or a PTCA procedure within one month of enrollment;
12. Subjects who have a biventricular pacemaker or whose primary care physician(s) believes a biventricular pacemaker is indicated;
13. Subjects who have had a myocardial infarction within three months of enrollment;
14. Subjects who have mechanical tricuspid or aortic valves;
15. Subjects who have a prior heart transplant;
16. Subjects who have a previously implanted ICD which employs unipolar or integrated bipolar sensing;
17. Subjects who are participating in another experimental protocol;
18. Subjects who are unable to provide informed consent.

研究实施时间：

Study execute time：

从 From 2005-07-06 00:00:00至 To 2013-07-05 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2005-07-06 00:00:00 至 To 2013-07-05 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 80

Group：

Two groups

Sample size：

干预措施：

An OPTIMIZER System will be implanted and patients will be evaluated at the following pre-determined time-points: 1 week, 3 months, 6 months and 12 months (Appendix I).

干预措施代码：

Intervention：

An OPTIMIZER System will be implanted and patients will be evaluated at the following pre-determined time-points: 1 week, 3 months, 6 months and 12 months (Appendix I).

Intervention code：

组别：

(to be continued)

样本量：

 0

Group：

(to be continued)

Sample size：

干预措施：

After implantation of the Optimizer System, the CRT device will remain active; thus patients will simultaneously receive CRT and CCM treatment.

干预措施代码：

Intervention：

After implantation of the Optimizer System, the CRT device will remain active; thus patients will simultaneously receive CRT and CCM treatment.

Intervention code：

组别：

(to be continued)

样本量：

 0

Group：

(to be continued)

Sample size：

干预措施：

After 1 year, patient will continue with long-term follow up and assessments according to standard clinical practice.

干预措施代码：

Intervention：

After 1 year, patient will continue with long-term follow up and assessments according to standard clinical practice.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 CUHK 

单位级别：

 CUHK 

Institution
hospital：

CUHK

Level of the institution：

CUHK

测量指标：

Outcomes：

指标中文名：

CCM will improve clinical and echocardiographic outcomes of the patient in CRT non-responders.

指标类型：

主要指标

Outcome：

CCM will improve clinical and echocardiographic outcomes of the patient in CRT non-responders.

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：

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：

暂停或中断

Suspending

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 98 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

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

Randomized 1:1

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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：

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2012-10-19 00:00:00