SJM MRI Diagnostic Imaging Registry (IDE)
- Conditions
- Cardiac Arrhythmia
- Interventions
- Device: Pacemaker, ICD, or CRT device
- Registration Number
- NCT02807948
- Lead Sponsor
- Abbott Medical Devices
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 189
- 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.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pacemaker, ICD, or CRT device patients Pacemaker, ICD, or CRT device Subjects who need a non-thoracic clinically indicated scan
- Primary Outcome Measures
Name Time Method The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. 1 month Based on the ability of the radiologist to read and provide a diagnosis/report.
The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation. 1 month Based on the ability of the radiologist to read and provide a diagnosis/report.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (58)
Advanced Radiology
🇺🇸Columbia, Missouri, United States
Scottsdale Medical Imaging
🇺🇸Scottsdale, Arizona, United States
St. Bernards
🇺🇸Jonesboro, Arkansas, United States
Raymond Schaerf, MD
🇺🇸Burbank, California, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
John Muir Medical Center
🇺🇸Concord, California, United States
Quest Imaging
🇺🇸Bakersfield, California, United States
Cardiovascular Consultants Heart Center
🇺🇸Fresno, California, United States
St. Helena Hospital
🇺🇸Deer Park, California, United States
Newport Diagnostic Center
🇺🇸Newport Beach, California, United States
Eisenhower Medical Center
🇺🇸Rancho Mirage, California, United States
Pro Health Advance Imaging
🇺🇸North Hollywood, California, United States
Sansum Clinic - Santa Barbara Medical Foundation
🇺🇸Santa Barbara, California, United States
Medical Center of the Rockies
🇺🇸Loveland, Colorado, United States
South Denver Cardiology Associates PC
🇺🇸Littleton, Colorado, United States
Christiana Hospital
🇺🇸Newark, Delaware, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Cardiac Arrhythmia Services
🇺🇸Boca Raton, Florida, United States
Jupiter Medical Center
🇺🇸Jupiter, Florida, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Piedmont Athens Regional Medical Center
🇺🇸Athens, Georgia, United States
King's Daughters Medical Center
🇺🇸Ashland, Kentucky, United States
Suburban Hospital
🇺🇸Bethesda, Maryland, United States
McLaren Health Care Corporation
🇺🇸Auburn Hills, Michigan, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
Baptist Medical Center
🇺🇸Jackson, Mississippi, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Kearney Regional Medical Center
🇺🇸Kearney, Nebraska, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, 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
Oregon Medical Group
🇺🇸Eugene, Oregon, United States
Denville Diagnostics and Open MRI LLC
🇺🇸Denville, New Jersey, United States
Samaritan Heart & Vascular Institute - Cardiology Dept.
🇺🇸Corvallis, Oregon, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Lehigh Valley Hospital - 17th Street
🇺🇸Allentown, Pennsylvania, United States
Trident Medical Center
🇺🇸Charleston, South Carolina, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
St. Mary Medical Center
🇺🇸Langhorne, Pennsylvania, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Allegheny Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Donald Guthrie Foundation for Education and Research
🇺🇸Sayre, Pennsylvania, United States
Baylor All Saints Medical Center at Fort Worth
🇺🇸Fort Worth, Texas, United States
East Texas Medical Center
🇺🇸Tyler, Texas, United States
Erlanger Medical Center
🇺🇸Chattanooga, Tennessee, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Lynchburg General Hospital
🇺🇸Lynchburg, Virginia, United States
Overlake Hospital Medical Center
🇺🇸Bellevue, Washington, United States
Aurora Medical Group
🇺🇸Milwaukee, Wisconsin, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Swedish Medical Center - Heart & Vascular
🇺🇸Seattle, Washington, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
St. Mary's Medical Center
🇺🇸San Francisco, California, United States
Community Heart and Vascular
🇺🇸Indianapolis, Indiana, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States