Trials / Completed
CompletedNCT02009696
ProMRI Study of the Entovis Pacemaker System (Phase B)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 221 (actual)
- Sponsor
- Biotronik, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 heart/chest or thoracic spine. |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2014-11-01
- Completion
- 2015-01-01
- First posted
- 2013-12-12
- Last updated
- 2015-11-25
- Results posted
- 2015-07-10
Locations
32 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02009696. Inclusion in this directory is not an endorsement.