Completed

NCT Number: NCT01117792

Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation

The primary objective is to evaluate the S-ICD system's ability to identify and terminate induced ventricular fibrillation in patients during the implant procedure. The safety and performance of the S-ICD system will also be assessed throughout the patient follow-up period.

Completed

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Key information

Conditions

ACC/AHA/NASPE Class 1, IIa or IIb Indications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico San Donato, San Donato Milanese, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Replacement of an existing implanted transvenous ICD system
Class I, Class IIa, or Class IIb ACC/AHA/HRS indications for patients without an existing transvenous ICD system
Age is >= 18 years
Appropriate pre-operative ECG as measured with a specially developed template

Exclusion criteria

Subjects unable or unwilling to provide informed consent
Any condition which precludes the subject's ability to comply with the study requirements
Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study
Participation in another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the sponsor.
Patients with a serious medical condition and life expectancy of less than one year.
Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing
Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
Patients with impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with a GFR <= 29.

Treatment and study plan