At a glance
ClinicalIndex Comparison RecordN/ACompleted· 466 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.
Clinical Investigation to Assess the Safety and Efficacy of the Tendril MRI™ Leads, as a Part of the Accent MRI™ System, in Patients With Standard Bradycardia Pacing Indication.
In Brief
An observational study for Bradycardia. Completed, enrolled 466 participants.
Detailed Summary
The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and Accent MRI™ pacemaker. The subject population includes patients with a standard bradycardia pacing indication.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBradycardia
Countries--
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedFeb 2012
Primary CompletionJun 2014
Study CompletionMar 2015
TodayJul 2026
First PostedFeb 7, 2012
Enrollment StartFeb 1, 2012
Primary CompletionJun 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.4 years ago