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.
1 other identifier
interventional
189
1 country
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 17, 2016
CompletedFirst Posted
Study publicly available on registry
June 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedResults Posted
Study results publicly available
August 26, 2019
CompletedAugust 26, 2019
August 1, 2019
1.6 years
June 17, 2016
August 7, 2019
August 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Pacemaker, ICD, or CRT device patients
OTHERSubjects who need a non-thoracic clinically indicated scan
Interventions
MRI Scans on SJM device implanted subjects for clinical purpose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Scottsdale Medical Imaging
Scottsdale, Arizona, 85258, United States
University of Arizona
Tucson, Arizona, 85719, United States
St. Bernards
Jonesboro, Arkansas, 72401, United States
Quest Imaging
Bakersfield, California, 93311, United States
Raymond Schaerf, MD
Burbank, California, 91505, United States
John Muir Medical Center
Concord, California, 94520, United States
St. Helena Hospital
Deer Park, California, 94576, United States
Cardiovascular Consultants Heart Center
Fresno, California, 93720, United States
Newport Diagnostic Center
Newport Beach, California, 92660, United States
Pro Health Advance Imaging
North Hollywood, California, 91602, United States
Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
St. Mary's Medical Center
San Francisco, California, 94117, United States
Sansum Clinic - Santa Barbara Medical Foundation
Santa Barbara, California, 93105, United States
South Denver Cardiology Associates PC
Littleton, Colorado, 80120, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Christiana Hospital
Newark, Delaware, 19718, United States
Cardiac Arrhythmia Services
Boca Raton, Florida, 33422, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Florida Hospital
Orlando, Florida, 32803, United States
Piedmont Athens Regional Medical Center
Athens, Georgia, 30606, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Prairie Education and Research Cooperative
Springfield, Illinois, 62701, United States
Community Heart and Vascular
Indianapolis, Indiana, 46250, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
King's Daughters Medical Center
Ashland, Kentucky, 25704, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71130, United States
Suburban Hospital
Bethesda, Maryland, 20814, United States
Washington Adventist Hospital
Takoma Park, Maryland, 20912, United States
McLaren Health Care Corporation
Auburn Hills, Michigan, 48326, United States
Baptist Medical Center
Jackson, Mississippi, 39202, United States
Advanced Radiology
Columbia, Missouri, 65201, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
Kearney Regional Medical Center
Kearney, Nebraska, 68845, United States
Denville Diagnostics and Open MRI LLC
Denville, New Jersey, 07834, United States
Borg and Ide Imaging
Rochester, New York, 14618, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Novant Clinical Research Institute
Winston-Salem, North Carolina, 27103, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Samaritan Heart & Vascular Institute - Cardiology Dept.
Corvallis, Oregon, 97330, United States
Oregon Medical Group
Eugene, Oregon, 97401, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
Lehigh Valley Hospital - 17th Street
Allentown, Pennsylvania, 19118, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-2150, United States
St. Mary Medical Center
Langhorne, Pennsylvania, 19047, United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212, United States
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 18840, United States
Trident Medical Center
Charleston, South Carolina, 29406, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, 76104, United States
East Texas Medical Center
Tyler, Texas, 75701, United States
Lynchburg General Hospital
Lynchburg, Virginia, 24501, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Overlake Hospital Medical Center
Bellevue, Washington, 98004, United States
Swedish Medical Center - Heart & Vascular
Seattle, Washington, 98122, United States
Aurora Medical Group
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Adam M.Cline, MD, MSc.- Principal Scientist
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Grant Kim
Abbott Medical Devices
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2016
First Posted
June 21, 2016
Study Start
June 1, 2016
Primary Completion
December 31, 2017
Study Completion
January 31, 2018
Last Updated
August 26, 2019
Results First Posted
August 26, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share