Acute Subcutaneous Defibrillation Study
Completed
- Conditions
- cardiac arrestventricular fibrillation10007521
- Registration Number
- NL-OMON40354
- Lead Sponsor
- Medtronic Trading NL BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Subject must be undergoing implant of an ICD or S-ICD® for approved indications
(In the Netherlands only patients who will recieve a S-ICD will be asked)
Exclusion Criteria
* Subject has LVEF < 15%
* Subject at high risk of stroke
* Subject having a device replacement
* Subject is indicated for CRT
* Subject is pacemaker dependent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the defibrillation efficacy of a subcutaneous defibrillation system<br /><br>using a sternal-lateral electrode configuration.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the feasibility to induce VF via the same sternal-lateral electrodes<br /><br>used for defibrillation, using a Medtronic-built Subcutaneous Induction Device<br /><br>(SQID). </p><br>