At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,766 enrolled
Drug / intervention
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.
Subcutaneous Implantable Cardioverter Defibrillator (S-ICD®) System Post Approval Study
In Brief
An observational study evaluating S-ICD System for Primary Prevention of Sudden Cardiac Arrest and Secondary Prevention of Sudden Cardiac Arrest. Completed, enrolled 1,766 participants across 87 sites.
Detailed Summary
The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartMar 2013
Primary CompletionOct 2021
TodayJul 2026
First PostedNov 29, 2012
Enrollment StartMar 12, 2013
Primary CompletionOct 15, 2021
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 13.6 years ago
Interventions
S-ICD Systemdevice