At a glance
ClinicalIndex Comparison RecordN/ACompleted· 229 enrolled
Drug / intervention
Patients with a ProMRI Pacemaker 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 Entovis Pacemaker System
In Brief
An observational study evaluating Patients with a ProMRI Pacemaker System and Magnetic Resonance Imaging (MRI) scan for Safety of the ProMRI Pacemaker System Under Specific MRI Conditions. Completed, enrolled 229 participants across 25 sites.
Detailed Summary
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartFeb 2013
Primary CompletionMar 2014
Study CompletionMay 2014
TodayJul 2026
First PostedJan 4, 2013
Enrollment StartFeb 1, 2013
Primary CompletionMar 1, 2014
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 13.5 years ago
Interventions
Patients with a ProMRI Pacemaker Systemdevice
Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scanother
MRI scan of head and lower back.