Trials / Completed
CompletedNCT02117414
Confirmatory Clinical Trial of the Evera MRI System for Conditionally-safe MRI Access
Evera MRI Clinical Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 275 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the Evera MRI™ study is to confirm safety and efficacy of the Evera MRI ICD (Implantable cardioverter-defibrillator) System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans without positioning restrictions (MRI scans may occur anywhere on the body).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MRI scan sequences of the head and chest regions | Non-diagnostic MRI scans |
| OTHER | Waiting Period Visit | Waiting period time will equate to 1 hour |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2015-01-01
- Completion
- 2015-09-01
- First posted
- 2014-04-21
- Last updated
- 2016-11-28
- Results posted
- 2015-08-14
Locations
42 sites across 13 countries: United States, Belgium, Canada, Chile, Germany, Hong Kong, Hungary, India, Italy, Netherlands, Saudi Arabia, Sweden, Switzerland
Source: ClinicalTrials.gov record NCT02117414. Inclusion in this directory is not an endorsement.