At a glance
ClinicalIndex Comparison RecordN/ACompleted· 6 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.
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
In Brief
A clinical study evaluating Subcutaneous Implantable Defibrillator (S-ICD) System for Ventricular Tachyarrhythmias. Completed, enrolled 6 participants across 2 sites.
Detailed Summary
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and followed for one month to collect data on the safety, efficacy, and performance of the implanted S-ICD system. Additionally, patient comfort will be assessed as will cosmetic outcome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVentricular Tachyarrhythmias
CountriesNew Zealand
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
Primary CompletionSep 2008
First PostedMar 2009
TodayJul 2026
First PostedMar 2, 2009
Enrollment StartJul 1, 2008
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.3 years ago
Interventions
Subcutaneous Implantable Defibrillator (S-ICD) Systemdevice