A study of implantable cardiac defibrillators (ICD; a device used to correct irregular heart rhythm) in a Chinese populatio
- Conditions
- Chinese population with primary prevention indication for ICD therapyCirculatory System
- Registration Number
- ISRCTN13448502
- Lead Sponsor
- Boston Scientific (United States)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 400
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method