Chinese population with primary prevention indication for ICD therapy Circulatory System
Conditions
Interventions
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.
Sponsors
Boston Scientific (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of inappropriate shock will be determined according the programming reports at 1, 3, 6, 12, 18 months after the procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
China
Contacts
Public ContactYaodong Li
Outcome results
None listed