At a glance
ClinicalIndex Comparison RecordN/ACompleted· 227 enrolled
Drug / intervention
Ellipse VR ICD and Durata/Optisure 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.
A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing Magnetic Resonance Imaging, an Investigational Device Exemption (IDE) Study
In Brief
A clinical study evaluating Ellipse VR ICD and Durata/Optisure lead for Implantable Defibrillator User. Completed, enrolled 227 participants across 32 sites in 5 countries.
Detailed Summary
To demonstrate safety and efficacy of the Durata or Optisure high voltage lead and Ellipse VR ICD in an MRI environment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImplantable Defibrillator User
CountriesHungary, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMay 2016
First PostedJun 2016
Primary CompletionJan 2017
Study CompletionApr 2018
TodayJul 2026
First PostedJun 1, 2016
Enrollment StartMay 1, 2016
Primary CompletionJan 12, 2017
Study CompletionApr 11, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.1 years ago
Interventions
Ellipse VR ICD and Durata/Optisure leaddevice
Non-diagnostic MRI Scan sequence of head and chest