N/A
Completed N=42
Acute Feasibility Investigation of a New S-ICD Electrode
Source: ClinicalTrials.gov NCT03802110 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
May 2024
Primary outcomePrimary: Defibrillation Threshold (DFT) of the New Shock Electrode Configuration in Joules — 27.0; 31.5 Joules
Summary
This is an early-stage feasibility study. This study seeks to characterize the performance of the new electrode shock configuration with the S-ICD
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Defibrillation Threshold (DFT) of the New Shock Electrode Configuration in Joules |
27.0; 31.5 | — |
| SECONDARY Number of Participants With Successful Ventricular Fibrillation (VF) Conversion at 40 Joules |
32; 18 | — |
Eligibility Criteria
Key Inclusion Criteria
- Subject is scheduled to receive a de novo S-ICD system implant per labeled indication.
- Passing S-ICD screening ECG performed per applicable user's manual.
- Subject is willing and capable of providing informed consent specific to local and national laws.
- Subject is age 18 or above, or of legal age to give informed consentspecific to local and national law.
Key Exclusion Criteria
- 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.
- Subject has a left ventricular ejection fraction ≤ 20% within 3 months prior to enrollment.
- Subject has NYHA Class IV or unstable Class III heart failure.
- Subject that, in the opinion of the investigator, cannot tolerate the DFT testing required by this protocol.
- Subject is morbidly obese, defined as BMI ≥ 35.
- Subject has an active infection or has been treated for infection within the past 30 days.
- Subject that, in the opinion of the investigator, has an increased risk of infection.
- Subject is currently requiring/receiving dialysis.
- Subject has insulin-dependent diabetes.
- Subject had/has any prior or planned other surgical procedure within ±30 days of enrollment.
- Subject that, in the opinion of the investigator, has an increased risk for thromboembolic event.
- Subject that, in the opinion of the investigator, has an increased risk of excessive bleeding.
- Subject is currently on an active heart transplant list.
Data sourced from ClinicalTrials.gov (NCT03802110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.