HVP_SJM-CIP-10130 MRI

A Clinical Evaluation of the Diagnostic Utility of MRI scans in patients implanted with St. Jude Medical pacemakers, ICDs, and CRTs

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.

Key Inclusion Criteria:

1. Patient is implanted with a market-released St. Jude Medical pacemaker, ICD, or CRT device after 2001 and any market-released pacing or defibrillation lead.
2. Patient's device and all leads must be implanted for at least 6 weeks prior to the scheduled date of the MRI.
3. Patient has a clinical indication for a non-thoracic MRI scan, where MRI is the imaging modality of choice that will give adequate results to manage the patient.
4. Patient is scheduled for a non-thoracic MRI scan up to 1.5T.
5. Patient has a pacemaker, ICD, or CRT device implanted pectorally.
6. Patient has the ability to provide informed consent for study participation and be willing and able to comply with the study procedures.
7. Patient is 18 years or above, or of legal age to give informed consent specific to state and national law.

See clinicaltrials.gov for full details.
Phase IV/V
NCT02807948
Heart and Vascular, All Other
Electrophysiology
Scott Brancato, , M.D.
St Jude Medical
Ellen Muir
  • Providence St. Vincent Medical Center