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.

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrhythmia
• Intervention / Treatment: Device: Pacemaker, ICD, or CRT device

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.

• Study Type: Interventional
• Enrollment (Actual): 189
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Scottsdale Medical Imaging
    • Tucson, Arizona, United States, 85719
      • University of Arizona
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • St. Bernards
  • California
    • Bakersfield, California, United States, 93311
      • Quest Imaging
    • Burbank, California, United States, 91505
      • Raymond Schaerf, MD
    • Concord, California, United States, 94520
      • John Muir Medical Center
    • Deer Park, California, United States, 94576
      • St. Helena Hospital
    • Fresno, California, United States, 93720
      • Cardiovascular Consultants Heart Center
    • Newport Beach, California, United States, 92660
      • Newport Diagnostic Center
    • North Hollywood, California, United States, 91602
      • Pro Health Advance Imaging
    • Rancho Mirage, California, United States, 92270
      • Eisenhower Medical Center
    • San Francisco, California, United States, 94117
      • St. Mary's Medical Center
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic - Santa Barbara Medical Foundation
  • Colorado
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates PC
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Hospital
  • Florida
    • Boca Raton, Florida, United States, 33422
      • Cardiac Arrhythmia Services
    • Jupiter, Florida, United States, 33458
      • Jupiter Medical Center
    • Orlando, Florida, United States, 32803
      • Florida Hospital
  • Georgia
    • Athens, Georgia, United States, 30606
      • Piedmont Athens Regional Medical Center
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital
    • Springfield, Illinois, United States, 62701
      • Prairie Education and Research Cooperative
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Community Heart and Vascular
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Kentucky
    • Ashland, Kentucky, United States, 25704
      • King's Daughters Medical Center
  • Louisiana
    • Shreveport, Louisiana, United States, 71130
      • LSU Health Sciences Center
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Suburban Hospital
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital
  • Michigan
    • Auburn Hills, Michigan, United States, 48326
      • McLaren Health Care Corporation
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Baptist Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65201
      • Advanced Radiology
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital St. Louis
  • Nebraska
    • Kearney, Nebraska, United States, 68845
      • Kearney Regional Medical Center
  • New Jersey
    • Denville, New Jersey, United States, 07834
      • Denville Diagnostics and Open MRI LLC
  • New York
    • Rochester, New York, United States, 14618
      • Borg and Ide Imaging
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Clinical Research Institute
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University
  • Oregon
    • Corvallis, Oregon, United States, 97330
      • Samaritan Heart & Vascular Institute - Cardiology Dept.
    • Eugene, Oregon, United States, 97401
      • Oregon Medical Group
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 19118
      • Lehigh Valley Hospital - 17th Street
    • Danville, Pennsylvania, United States, 17822-2150
      • Geisinger Medical Center
    • Langhorne, Pennsylvania, United States, 19047
      • St. Mary Medical Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Singer Research Institute
    • Sayre, Pennsylvania, United States, 18840
      • Donald Guthrie Foundation for Education and Research
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Trident Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Medical Center
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Baylor All Saints Medical Center at Fort Worth
    • Tyler, Texas, United States, 75701
      • East Texas Medical Center
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Lynchburg General Hospital
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Hospital Medical Center
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center - Heart & Vascular
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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.
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.

Exclusion Criteria:

1. Patient has an ICD/CRT-D and is pacemaker dependent
2. Capture threshold is greater than 2.5 volts at 0.5 ms for RA and RV leads
3. Pacing lead impedance is NOT within range (i.e. ≥ 200 and ≤ 2000 ohms)
4. High voltage lead impedance (HVLI) is NOT within range (i.e. ≥ 20 and ≤ 200 ohms)
5. Patient has a device generator battery voltage at elective replacement interval (ERI)
6. 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.

7. 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
8. Patient has a lead extender, adaptor, or capped/abandoned lead
9. Patient is pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Grant Kim, Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: June 17, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: MRI Scan, pacemakers, ICD, CRT
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: SJM-CIP-10130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No