ProMRI Study of the Entovis Pacemaker System
NCT01761162 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 229
Last updated 2017-02-09
Summary
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.
Conditions
- Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
Interventions
- DEVICE
-
Patients with a ProMRI Pacemaker System
Bradycardia Slow Heart Beat
- OTHER
-
Magnetic Resonance Imaging (MRI) scan
MRI scan of head and lower back.
Sponsors & Collaborators
-
Biotronik, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2014-03-31
- Completion
- 2014-05-31
Countries
- United States
Study Locations
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