Acute Subcutaneous Defibrillation (ASQ)

Medtronic

Status: Completed

Conditions: Ventricular Arrhythmias

Study type: Observational

Funder types: Industry

Identifiers

NCT01771172

ASQ

Details and patient eligibility

About

To assess the defibrillation efficacy of a subcutaneous defibrillation system.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)