Trials / Completed
CompletedNCT01761162
ProMRI Study of the Entovis Pacemaker System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 229 (actual)
- Sponsor
- Biotronik, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Patients with a ProMRI Pacemaker System | Bradycardia Slow Heart Beat |
| OTHER | Magnetic Resonance Imaging (MRI) scan | MRI scan of head and lower back. |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2014-03-01
- Completion
- 2014-05-01
- First posted
- 2013-01-04
- Last updated
- 2017-02-09
- Results posted
- 2014-11-04
Locations
25 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01761162. Inclusion in this directory is not an endorsement.