At a glance
ClinicalIndex Comparison RecordN/ACompleted· 275 enrolled
Drug / intervention
MRI scan sequences of the head and chest regions +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.
Evera MRI Clinical Study
In Brief
A clinical study evaluating MRI scan sequences of the head and chest regions and Waiting Period Visit for Implantable Defibrillator. Completed, enrolled 275 participants across 42 sites in 13 countries.
Detailed Summary
The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI scans may occur anywhere on the body).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImplantable Defibrillator
CountriesBelgium, Canada, Chile, Germany, Hong Kong, Hungary, India, Italy, Netherlands, Saudi Arabia, Sweden, Switzerland, United States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedApr 2014
Primary CompletionJan 2015
Study CompletionSep 2015
TodayJul 2026
First PostedApr 21, 2014
Enrollment StartApr 1, 2014
Primary CompletionJan 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.2 years ago
Interventions
MRI scan sequences of the head and chest regionsdevice
Non-diagnostic MRI scans
Waiting Period Visitother
Waiting period time will equate to 1 hour