Trials / Completed
CompletedNCT02175797
Assessment of the MRI Solution: KORA 100 and Beflex Pacing Leads System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- MicroPort CRM · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to report the stability of atrial and ventricular leads by absence of effect of the MRI exam on the pacing and sensing threshold and to report the safety based on the serious adverse events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MRI | at least 6 weeks after the implantation of the pacemaker a MRI exam is performed |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2014-08-01
- Completion
- 2014-08-01
- First posted
- 2014-06-26
- Last updated
- 2019-04-23
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02175797. Inclusion in this directory is not an endorsement.