N/A
N=42
Acute Feasibility Investigation of a New S-ICD Electrode
Ventricular Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT03802110 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
May 2024
Primary outcome: Primary: Defibrillation Threshold (DFT) of the New Shock Electrode Configuration in Joules — 27.0; 31.5 Joules
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Apr 2022
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 | — |
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
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.