Acute Subcutaneous Defibrillation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-06-30

Brief Summary

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To assess the defibrillation efficacy of a subcutaneous defibrillation system.

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Detailed Description

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Conditions

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Ventricular Arrhythmias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No