Trials / Completed
CompletedNCT01781078
ImageReady(TM) MR Conditional Pacing System Clinical Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 363 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with the Conditions of Use included in the Boston Scientific MRI Technical Guide
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | MRI | The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment |
| DEVICE | ImageReady System implant | Pacemaker and lead(s) implant |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2014-10-01
- Completion
- 2019-09-11
- First posted
- 2013-01-31
- Last updated
- 2019-12-03
- Results posted
- 2017-04-11
Locations
41 sites across 7 countries: United States, Australia, Canada, China, Israel, Malaysia, Singapore
Source: ClinicalTrials.gov record NCT01781078. Inclusion in this directory is not an endorsement.