At a glance
ClinicalIndex Comparison RecordN/ACompleted· 221 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 (Phase B)
In Brief
An observational study evaluating Patients with a ProMRI Pacemaker System and Magnetic Resonance Imaging (MRI) scan for Magnetic Resonance Imaging (MRI); Cardiac Pacing. Completed, enrolled 221 participants across 32 sites.
Detailed Summary
The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedDec 2013
Primary CompletionNov 2014
Study CompletionJan 2015
TodayJul 2026
First PostedDec 12, 2013
Enrollment StartDec 1, 2013
Primary CompletionNov 1, 2014
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.6 years ago
Interventions
Patients with a ProMRI Pacemaker Systemdevice
Bradycardia Slow Heart Beat
Magnetic Resonance Imaging (MRI) scanother
MRI scan of heart/chest or thoracic spine.