At a glance
ClinicalIndex Comparison RecordN/ACompleted· 950 enrolled
Drug / intervention
Accent MRI system (lead safety) +1 moredevice
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.
Accent Magnetic Resonance Imaging Pacemaker and Tendril Magnetic Resonance Imaging™ Lead Investigational Device Exemption Study
In Brief
A clinical study evaluating Accent MRI system (lead safety) and Accent MRI system (with MRI scan) for Adverse Effect of MRI on an Implanted Pacemaker Lead and Adverse Effect of MRI on an Implanted Pacemaker. Completed, enrolled 950 participants across 70 sites in 5 countries.
Detailed Summary
The MRI Study is a prospective, multi-center, clinical study designed to evaluate the safety and efficacy of the Accent MRI™ System in a patient population indicated for implant of a pacemaker within and outside of the MRI environment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdverse Effect of MRI on an Implanted Pacemaker Lead, Adverse Effect of MRI on an Implanted Pacemaker
CountriesAustralia, Belgium, Finland, Netherlands, United States
Collaborators--
Timeline
N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2012
First PostedApr 2012
Primary CompletionFeb 2018
TodayJul 2026
First PostedApr 12, 2012
Enrollment StartMar 30, 2012
Primary CompletionFeb 2, 2018
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 14.2 years ago
Interventions
Accent MRI system (lead safety)device
Patients implanted with an Accent MRI system
Accent MRI system (with MRI scan)device
Patients implanted with an Accent MRI system will receive an MRI scan