CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
subcutaneous implantable defibrillator (S-ICD) systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01117792
NCT01117792N/ACompleted
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Subcutaneous Implantable Defibrillator (S-ICD) System - CE Clinical Investigation

Boston Scientific Corporation·interventional·Posted May 5, 2010·Updated Jul 2, 2021

In Brief

A clinical study evaluating subcutaneous implantable defibrillator (S-ICD) system for ACC/AHA/NASPE Class 1, IIa or IIb Indications. Completed, enrolled 55 participants across 8 sites in 4 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsACC/AHA/NASPE Class 1, IIa or IIb Indications
CountriesItaly, Netherlands, New Zealand, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 5, 2010
Enrollment StartDec 1, 2008
Primary CompletionMar 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.2 years ago

Interventions

subcutaneous implantable defibrillator (S-ICD) systemdevice

implantable defibrillator system