N/A
Completed N=48
Acute Subcutaneous Defibrillation
Source: ClinicalTrials.gov NCT01771172 ↗Enrolled (actual)
48
Serious AEs
18.0%
Results posted
Dec 2016
Primary outcomePrimary: Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System. — 85.7 percentage of success
Summary
To assess the defibrillation efficacy of a subcutaneous defibrillation system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Will Demonstrate a Successful Defibrillation Outcome if They Have 2 Successful Defibrillation Shocks With the Research System. |
85.7 | — |
Eligibility Criteria
Inclusion Criteria
- Subject must be undergoing implant of a commercially approved ICD system
- Subject must be willing to provide Informed Consent
- Subject must be > 18 years old
Exclusion Criteria
- Subject with impaired kidney function as measured by a glomerular filtration rate (eGFR) estimate < 29 mls/min/1.73m2 (recorded in the last six months)
- Subject has high risk of infection
- Subject has EF < 15%
- Subject at high risk of stroke
- having a device replacement
- Subject with an implanted active non-ICD device, cardiac or non-cardiac (e.g., Neuro stimulator, Pacemaker)
- Subject is indicated for CRT
- Subject is pacemaker dependent
- Subject enrolled in a concurrent study that may confound the results of this study
- Subject has medical conditions that would limit study participation
- Subject is pregnant
- Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)
Data sourced from ClinicalTrials.gov (NCT01771172). 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.