SJM MRI Diagnostic Imaging Registry (IDE)

Study Overview
=================
Brief 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.

Official Title
-----------------
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.

Conditions
-----------------
Cardiac Arrhythmia

Intervention / Treatment
-----------------
* Device: Pacemaker, ICD, or CRT device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is implanted with a market-released St. Jude Medical pacemaker, ICD, or CRT current generation device listed in the study protocol and any market-released pacing or defibrillation lead. Patient's device and all leads must be implanted for at least 6 weeks prior to the scheduled date of the MRI. 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. Patient is scheduled for a non-thoracic MRI scan up to 1.5T. Patient has a pacemaker, ICD, or CRT device implanted pectorally. Patient has the ability to provide informed consent for study participation and be willing and able to comply with the study procedures. Patient is 18 years or above, or of legal age to give informed consent specific to state and national law. Exclusion Criteria: Patient has an ICD/CRT-D and is pacemaker dependent Capture threshold is greater than 2.5 volts at 0.5 ms for RA and RV leads Pacing lead impedance is NOT within range (i.e. ≥ 200 and ≤ 2000 ohms) High voltage lead impedance (HVLI) is NOT within range (i.e. ≥ 20 and ≤ 200 ohms) Patient has a device generator battery voltage at elective replacement interval (ERI) Patient has another existing active implanted medical device (e.g. neurostimulator, infusion pump, etc.) that has MR labeling that will not allow the MRI scans to be completed. Patient has other non-MRI compatible device or material implanted NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol Non-removable dental implants may be included Patient has a lead extender, adaptor, or capped/abandoned lead Patient is pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pacemaker, ICD, or CRT device patients<br>Subjects who need a non-thoracic clinically indicated scan | Device: Pacemaker, ICD, or CRT device<br>* MRI Scans on SJM device implanted subjects for clinical purpose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. | Based on the ability of the radiologist to read and provide a diagnosis/report. | 1 month | 
| The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. | Based on the ability of the radiologist to read and provide a diagnosis/report. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI Scan, pacemakers, ICD, CRT