Acute Feasibility Investigation of a New S-ICD Electrode Arrangement for Reduction of Defibrillation Energies

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 42

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Defibrillation Threshold (DFT) of the two-electrode shock configuration<br /><br>(Parallel and 90º)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* VF conversion success for the two-electrode shock configuration (Parallel and<br /><br>90º)<br /><br>* Shock impedance of both the one- and two-electrode shock configurations<br /><br>(Parallel and 90º)</p><br>