Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
189 participants
INTERVENTIONAL
2016-06-30
2018-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Pacemaker, ICD, or CRT device patients
Subjects who need a non-thoracic clinically indicated scan
Pacemaker, ICD, or CRT device
MRI Scans on SJM device implanted subjects for clinical purpose
Interventions
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Pacemaker, ICD, or CRT device
MRI Scans on SJM device implanted subjects for clinical purpose
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Grant Kim
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
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Scottsdale Medical Imaging
Scottsdale, Arizona, United States
University of Arizona
Tucson, Arizona, United States
St. Bernards
Jonesboro, Arkansas, United States
Quest Imaging
Bakersfield, California, United States
Raymond Schaerf, MD
Burbank, California, United States
John Muir Medical Center
Concord, California, United States
St. Helena Hospital
Deer Park, California, United States
Cardiovascular Consultants Heart Center
Fresno, California, United States
Newport Diagnostic Center
Newport Beach, California, United States
Pro Health Advance Imaging
North Hollywood, California, United States
Eisenhower Medical Center
Rancho Mirage, California, United States
St. Mary's Medical Center
San Francisco, California, United States
Sansum Clinic - Santa Barbara Medical Foundation
Santa Barbara, California, United States
South Denver Cardiology Associates PC
Littleton, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Cardiac Arrhythmia Services
Boca Raton, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Florida Hospital
Orlando, Florida, United States
Piedmont Athens Regional Medical Center
Athens, Georgia, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Community Heart and Vascular
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
King's Daughters Medical Center
Ashland, Kentucky, United States
LSU Health Sciences Center
Shreveport, Louisiana, United States
Suburban Hospital
Bethesda, Maryland, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
McLaren Health Care Corporation
Auburn Hills, Michigan, United States
Baptist Medical Center
Jackson, Mississippi, United States
Advanced Radiology
Columbia, Missouri, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Mercy Hospital St. Louis
St Louis, Missouri, United States
Kearney Regional Medical Center
Kearney, Nebraska, United States
Denville Diagnostics and Open MRI LLC
Denville, New Jersey, United States
Borg and Ide Imaging
Rochester, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Novant Clinical Research Institute
Winston-Salem, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Samaritan Heart & Vascular Institute - Cardiology Dept.
Corvallis, Oregon, United States
Oregon Medical Group
Eugene, Oregon, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Lehigh Valley Hospital - 17th Street
Allentown, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
St. Mary Medical Center
Langhorne, Pennsylvania, United States
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, United States
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, United States
Trident Medical Center
Charleston, South Carolina, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, United States
East Texas Medical Center
Tyler, Texas, United States
Lynchburg General Hospital
Lynchburg, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Overlake Hospital Medical Center
Bellevue, Washington, United States
Swedish Medical Center - Heart & Vascular
Seattle, Washington, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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SJM-CIP-10130
Identifier Type: -
Identifier Source: org_study_id
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