Trials / Completed
CompletedNCT02096692
ProMRI Study of the Iforia ICD System (Phase C)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 154 (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 ICD System when used under specific MRI conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Patients with a ProMRI ICD System | Tachycardia Fast Heart Beat |
| OTHER | Magnetic Resonance Imaging (MRI) scan | MRI scan of heart/chest or thoracic spine |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2015-03-01
- Completion
- 2015-06-01
- First posted
- 2014-03-26
- Last updated
- 2016-02-29
- Results posted
- 2015-10-22
Locations
39 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02096692. Inclusion in this directory is not an endorsement.