Trials / Completed
CompletedNCT00433654
EMRI SureScan™ Clinical Study
EnRhythm MRI™ SureScan™ Pacing System Clinical Investigation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 484 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to confirm safety and efficacy in the clinical magnetic resonance imaging (MRI) environment of the investigational EnRhythm MRI™ SureScan™ Pacing System (used in support of Revo MRI™ SureScan Pacing System launch).
Detailed description
This study is a prospective, multi-center global study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantable Pulse Generator (IPG) and Pacing Leads (wires) | Pacer and leads |
| OTHER | Magnetic Resonance Imaging (MRI) scan | One hour MRI scan on the head and lower back. |
Timeline
- Start date
- 2007-02-01
- Primary completion
- 2008-11-01
- Completion
- 2010-08-01
- First posted
- 2007-02-12
- Last updated
- 2025-09-15
- Results posted
- 2011-08-11
Locations
45 sites across 11 countries: United States, Austria, Belgium, Canada, Czechia, France, Germany, Italy, Netherlands, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00433654. Inclusion in this directory is not an endorsement.