A study of implantable cardiac defibrillators (ICD; a device used to correct irregular heart rhythm) in a Chinese population
| ISRCTN | ISRCTN13448502 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13448502 |
- Submission date
- 21/05/2021
- Registration date
- 10/06/2021
- Last edited
- 22/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
An implantable cardioverter-defibrillator (ICD) is a small battery-powered device placed in your chest to monitor your heart rhythm and detect irregular heartbeats. An ICD can deliver electric shocks via one or more wires connected to your heart to fix an abnormal heart rhythm.
The subcutaneous implantable cardioverter–defibrillator (S-ICD) was designed to avoid complications related to the transvenous implantable cardioverter–defibrillator (TV-ICD) lead by using an entirely extrathoracic placement. The safety and effectiveness of S-ICD have been exhibited by many international multicenter studies, however, none of these observational studies involved the Chinese population.
This study aims to observe the incidence of inappropriate shock (IAS) at 18 months after S-ICD implantation in the Chinese population.
Who can participate?
Patients aged 18 years or older who are recommended to have ICD therapy
What does the study involve?
All the subjects will be followed up for 18 months after the procedure. The intraoperative parameters and complications, the occurrence of inappropriate shock, appropriate shock, ATP therapy, successful conversion, cardiac death, and device-related complication will be analyzed.
What are the possible benefits and risks of participating?
The treatment and follow-up frequency included in this observational study consists of the real-world clinic process and conforms to the consensus recommendation. Thus this is no additional benefits or risks.
Where is the study run from?
The First Affiliated Hospital of Xinjiang Medical University (China)
When is the study starting and how long is it expected to run for?
January 2021 to April 2024
Who is funding the study?
Boston Scientific Inc (USA)
Who is the main contact?
Tang Baopeng, tangbaopeng111@163.com
Contact information
Public
The First Affiliated Hospital of Xinjiang Medical University
No 137
Liyu South Road
Urumqi
830054
China
 ORCID ID |
0000-0003-1805-9433 |
|---|---|
| Phone | +86 15099538881 |
| boylyd@163.com |
Study information
| Study design | Multicenter prospective observational cohort |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | The application prospect of subcutaneous and transvenous ICD in Chinese population with primary prevention indication |
| Study acronym | SCOPE |
| Study objectives | Proportion of subjects that free from inappropriate shock through month 18 after the procedure is more than the performance goal of 90.3%. |
| Ethics approval(s) | Approved 03/06/2021, The First Affiliated Hospital of Xinjiang Medical University (No 137, Liyu South Road, Urumqi, Xinjiang, China, 830054; +86 15276535185; 393518493@qq.com), ref: K202103-06 |
| Health condition(s) or problem(s) studied | Chinese population with primary prevention indication for ICD therapy |
| Intervention | All the subjects will be followed up for 18 months after the procedure to observe the occurrences of inappropriate shock, appropriate shock, device related complications and cardiac death. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | implantable cardiac defibrillator |
| Primary outcome measure | Occurrence of inappropriate shock will be determined according the programming reports at 1, 3, 6, 12, 18 months after the procedure. |
| Secondary outcome measures | 1. Occurrence of appropriate shock will be determined according the programming reports at 1, 3, 6, 12, 18 months after the procedure 2. Success rate of conversion will be determined according the programming reports at 1, 3, 6, 12, 18 months after the procedure 3. Occurrence of cardiac death and device related complications will be determined by clinicians at 1, 3, 6, 12, 18 months after the procedure |
| Overall study start date | 01/01/2021 |
| Completion date | 01/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Age >18 years 2. The subjects met the class I or class II indications for ICD therapy for primary prevention 3. Subjects can be screened by S-ICD ECG 4. The subjects are willing and able to sign informed consent and attend all relevant visits on time |
| Key exclusion criteria | 1. Pregnant 2. Subjects are participating in other clinical trials, which may affect this study 3. The researchers determined that the subjects were not suitable for S-ICD implantation, such as patients need or will need pacing therapy for bradycardia; Subjects with known ventricular tachycardia at a rate below 170 beats per minute or with refractory recurrent monomorphic ventricular tachycardia that could not be managed with medication or ablation therapy 4. Subjects implanted with a transvenous CRT-D or with history of pacemaker or ICD 5. Subjects with paced rhythms at baseline or post-implant of TV-ICD 6. Life expectancy <18 months |
| Date of first enrolment | 21/06/2021 |
| Date of final enrolment | 01/10/2023 |
Locations
Countries of recruitment
- China
Study participating centres
Liyu South Road
Urumqi
830054
China
Xuhui District
Shanghai
200032
China
Xicheng District
Beijing
100037
China
Chaoyang District
Beijing
100029
China
Government District
Hefei
230031
China
Xihu District
Hangzhou
310012
China
Jinnan District
Tianjin
300222
China
Yuexiu District
Guangzhou
510030
China
Meijiang District
Meizhou
514031
China
27th District
Zhengzhou
450000
China
Pan-Asia Science and Technology New District
Wuhua District
Kunming
650000
China
Shapingba District
Chongqing
400037
China
Yuelu District, Hexi
Changsha
410200
China
First Ring Road
Qingyang District
Chengdu
610072
China
Xuhui District
Shanghai
200030
China
Taiyuan City
Taiyuan
030024
China
Wuhua District
Kunming
650032
China
Yanta District
Xi 'an
710061
China
Wuhou District
Chengdu
610041
China
Jinshui District
Zhengzhou
450000
China
Nangang District
Harbin
150001
China
Sponsor information
Industry
No. 763 Mengzi Road
Huangpu District
Shanghai
200023
China
| Phone | +86 15104673346 |
|---|---|
| XIUYUE.JIA@bsci.com | |
| Website | http://www.bostonscientific.com/en-US/home.html |
"ROR" |
https://ror.org/0385es521 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Boston Scientific, Boston Scientific Corp., BSC
- Location
- United States of America
Results and Publications
| Intention to publish date | 01/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 08/07/2021 | No | No | ||
| Results article | 24/02/2024 | 22/07/2025 | Yes | No |
Additional files
- ISRCTN13448502_PROTOCOL.pdf
- Uploaded 08/07/2021
Editorial Notes
22/07/2025: Publication reference added.
05/09/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 16/03/2021 to 21/06/2021.
2. The recruitment end date was changed from 01/10/2022 to 01/10/2023.
08/07/2021: Uploaded protocol (not peer reviewed).
07/06/2021: Trial's existence confirmed by The First Affiliated Hospital of Xinjiang Medical University.
