At a glance
ClinicalIndex Comparison RecordN/ACompleted· 154 enrolled
Drug / intervention
Patients with a ProMRI ICD System +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.
ProMRI Study of the Iforia ICD System (Phase C)
In Brief
An observational study evaluating Patients with a ProMRI ICD System and Magnetic Resonance Imaging (MRI) scan for Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging. Completed, enrolled 154 participants across 39 sites.
Detailed Summary
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartJun 2014
Primary CompletionMar 2015
Study CompletionJun 2015
TodayJul 2026
First PostedMar 26, 2014
Enrollment StartJun 1, 2014
Primary CompletionMar 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.3 years ago
Interventions
Patients with a ProMRI ICD Systemdevice
Tachycardia Fast Heart Beat
Magnetic Resonance Imaging (MRI) scanother
MRI scan of heart/chest or thoracic spine