At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,820 enrolled
Drug / intervention
Not specified
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.
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
In Brief
An observational study for Primary Prevention of Sudden Cardiac Arrest and Secondary Prevention of Sudden Cardiac Arrest. Completed, enrolled 1,820 participants across 111 sites in 3 countries.
Detailed Summary
Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
CountriesAustralia, Canada, United States
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartApr 2013
Primary CompletionFeb 2020
TodayJul 2026
First PostedMay 11, 2012
Enrollment StartApr 4, 2013
Primary CompletionFeb 18, 2020
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 14.1 years ago