At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,701 enrolled
Drug / intervention
SJ4 connector and RV high voltage SJ4 leaddevice
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.
SJ4 Post Approval Study
In Brief
An observational study evaluating SJ4 connector and RV high voltage SJ4 lead for Tachyarrhythmias and 2 related conditions. Completed, enrolled 1,701 participants across 1 site.
Detailed Summary
The purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsTachyarrhythmias, Sudden Cardiac Death, Heart Failure
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJul 2009
Primary CompletionSep 2015
Study CompletionDec 2015
TodayJul 2026
First PostedJul 16, 2009
Enrollment StartJun 1, 2009
Primary CompletionSep 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 17.0 years ago
Interventions
SJ4 connector and RV high voltage SJ4 leaddevice
Standard of care implantation of SJ4 device system