Trials / Completed
CompletedNCT01755143
Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment
CapSureFix® Novus Model 5076 Lead MRI Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 266 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to test the safety and effectiveness of the Medtronic CapSureFix Novus Model 5076 lead when patients are implanted with the Medtronic Advisa MRI pacemaker and undergo an MRI scan.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Magnetic Resonance Imaging scan sequences of the head, neck, and chest | |
| DEVICE | Pacemaker System |
Timeline
- Start date
- 2012-12-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2012-12-24
- Last updated
- 2015-07-20
- Results posted
- 2015-07-20
Locations
36 sites across 19 countries: Australia, Austria, Belgium, Chile, China, Colombia, Germany, Hong Kong, India, Netherlands, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan
Source: ClinicalTrials.gov record NCT01755143. Inclusion in this directory is not an endorsement.