cardiovascular disease
Conditions
Interventions
None listed
Sponsors
Boston Scientific
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is scheduled to receive a de novo S-ICD system implant per labeled indication 2. Passing S-ICD screening ECG performed per applicable user's manual. 3. Subject is expected to be implanted with a left parasternal S-ICD electrode. 4. Subject*s planned S-ICD implant procedure will include at least one VF conversion testing at 65 J. 5. Subject is willing and capable of providing informed consent specific to local and national laws. 6. Subject is age 18 or above, or of legal age to give informed consent specific to local and national law.
Exclusion criteria
Exclusion criteria: 1. Subject has an unusual chest anatomy (eg. pectus excavatum and pectus carinatum) that might impede the ability to temporarily insert a second S-ICD electrode. 2. Subject has a left ventricular ejection fraction less than or equal to 20% within 3 months prior to enrollment. 3. Subject has NYHA Class IV or unstable Class III heart failure. 4. Subject that, in the opinion of the investigator, cannot tolerate the DFT testing required by this protocol. 5. Subject that, in the opinion of the investigator, is at increased risk for VF conversion failure. 6. Subject is morbidly obese, defined as BMI greater than or equal to 35. 7. Subject has an active infection or has been treated for infection within the past 30 days. 8. Subject that, in the opinion of the investigator, has an increased risk of infection. 9. Subject is currently requiring/receiving dialysis. 10. Subject has insulin-dependent diabetes. 11. Subject had/has any prior or planned other surgical procedure within ±30 days of enrollment. 12. Subject is receiving immunosupressive therapy or has a condition that compromises their immune system. 13. Subject had episodes of atrial fibrillation or atrial flutter within the 4 week period prior to enrollment or during the period of time between enrollment and the start of implant procedure. 14. Subject that, in the opinion of the investigator, has an increased risk for thromboembolic event. 15. Subject that, in the opinion of the investigator, has an increased risk of excessive bleeding. 16. Subject is currently on an active heart transplant list. 17. Subjects with documented life expectancy of less than 12 months. 18. Subject has any other electrically active implanted device that cannot be temporarily deactivated during the implant (includes components or accessories present such as pulse generators, non-capped leads or leads with breached insulation, implantable cardiac monitors, implantable stimulators). 19. Subject is enrolled in a concurrent study, with the exception of local mandatory governmental registries and observational studies/registries, without prior written approval from Boston Scientific. 20. Women of childbearing potential who are or might be pregnant at the time of the S-ICD implant procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defibrillation Threshold (DFT) of the two-electrode shock configuration (Parallel and 90º) | — |
Secondary
| Measure | Time frame |
|---|---|
| * VF conversion success for the two-electrode shock configuration (Parallel and 90º) * Shock impedance of both the one- and two-electrode shock configurations (Parallel and 90º) | — |
Countries
Netherlands
Outcome results
None listed