Trials / Completed
CompletedNCT02877693
A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 205 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.
Detailed description
This clinical investigation is a prospective, multicenter, Asian study. The study was designed with two (2) parts, however only the 1st part was completed. For the 1st part, patients were enrolled with a SJM MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines. The 2nd part-meant to enroll patients for thoracic scans with 3 Tesla MRI scanning machines-was not completed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Thoracic MRI Scan | The ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized. |
Timeline
- Start date
- 2016-10-10
- Primary completion
- 2020-03-23
- Completion
- 2020-03-23
- First posted
- 2016-08-24
- Last updated
- 2023-12-08
- Results posted
- 2023-12-08
Locations
20 sites across 3 countries: India, Malaysia, South Korea
Source: ClinicalTrials.gov record NCT02877693. Inclusion in this directory is not an endorsement.