Trials / Completed
CompletedNCT02807948
SJM MRI Diagnostic Imaging Registry (IDE)
A Clinical Evaluation of the Diagnostic Utility of MRI Scans in Patients Implanted With St. Jude Medical Pacemakers, Implantable Cardioverter Defibrillator, and Cardiac Resynchronization Therapy Devices.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 189 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a prospective, non-randomized, multi-center study of subjects implanted with an SJM pacemakers, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices who are clinically indicated for a non-thoracic MRI scan.
Detailed description
This study will be performed as part of a regulated, prospective, non-randomized, multi-center clinical study. Subjects will be enrolled, undergo a clinically-indicated MRI scan, and have an assessment of adverse events, device measurements, and clinical utility of the MRI scan images.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pacemaker, ICD, or CRT device | MRI Scans on SJM device implanted subjects for clinical purpose |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2017-12-31
- Completion
- 2018-01-31
- First posted
- 2016-06-21
- Last updated
- 2019-08-26
- Results posted
- 2019-08-26
Locations
58 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02807948. Inclusion in this directory is not an endorsement.