Back to resultsSJM MRI Diagnostic Imaging Registry (IDE)
Primary Purpose
Cardiac Arrhythmia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pacemaker, ICD, or CRT device
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Arrhythmia focused on measuring MRI Scan, pacemakers, ICD, CRT
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
Sites / Locations
- Scottsdale Medical Imaging
- University of Arizona
- St. Bernards
- Quest Imaging
- Raymond Schaerf, MD
- John Muir Medical Center
- St. Helena Hospital
- Cardiovascular Consultants Heart Center
- Newport Diagnostic Center
- Pro Health Advance Imaging
- Eisenhower Medical Center
- St. Mary's Medical Center
- Sansum Clinic - Santa Barbara Medical Foundation
- South Denver Cardiology Associates PC
- Medical Center of the Rockies
- Hartford Hospital
- Christiana Hospital
- Cardiac Arrhythmia Services
- Jupiter Medical Center
- Florida Hospital
- Piedmont Athens Regional Medical Center
- Advocate Lutheran General Hospital
- Prairie Education and Research Cooperative
- Community Heart and Vascular
- Kansas University Medical Center
- King's Daughters Medical Center
- LSU Health Sciences Center
- Suburban Hospital
- Washington Adventist Hospital
- McLaren Health Care Corporation
- Baptist Medical Center
- Advanced Radiology
- St. Luke's Hospital
- Mercy Hospital St. Louis
- Kearney Regional Medical Center
- Denville Diagnostics and Open MRI LLC
- Borg and Ide Imaging
- St. Francis Hospital
- Novant Clinical Research Institute
- The Cleveland Clinic Foundation
- Ohio State University
- Samaritan Heart & Vascular Institute - Cardiology Dept.
- Oregon Medical Group
- Providence St. Vincent Medical Center
- Lehigh Valley Hospital - 17th Street
- Geisinger Medical Center
- St. Mary Medical Center
- Allegheny Singer Research Institute
- Donald Guthrie Foundation for Education and Research
- Trident Medical Center
- Erlanger Medical Center
- Baylor All Saints Medical Center at Fort Worth
- East Texas Medical Center
- Lynchburg General Hospital
- Sentara Norfolk General Hospital
- Overlake Hospital Medical Center
- Swedish Medical Center - Heart & Vascular
- Aurora Medical Group
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pacemaker, ICD, or CRT device patients
Arm Description
Subjects who need a non-thoracic clinically indicated scan
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02807948
Brief Title
SJM MRI Diagnostic Imaging Registry (IDE)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
January 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia
Keywords
MRI Scan, pacemakers, ICD, CRT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pacemaker, ICD, or CRT device patients
Arm Type
Other
Arm Description
Subjects who need a non-thoracic clinically indicated scan
Intervention Type
Device
Intervention Name(s)
Pacemaker, ICD, or CRT device
Intervention Description
MRI Scans on SJM device implanted subjects for clinical purpose
Primary Outcome Measure Information:
Title
The Proportion of MRI Scans From Pacemakers or CRT-Ps Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
Description
Based on the ability of the radiologist to read and provide a diagnosis/report.
Time Frame
1 month
Title
The Proportion of MRI Scans From ICDs or CRT-Ds Providing Sufficient Image Quality to Allow for a Diagnostic Interpretation.
Description
Based on the ability of the radiologist to read and provide a diagnosis/report.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant Kim
Organizational Affiliation
Abbott Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
Scottsdale Medical Imaging
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
St. Bernards
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Quest Imaging
City
Bakersfield
State/Province
California
ZIP/Postal Code
93311
Country
United States
Facility Name
Raymond Schaerf, MD
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
John Muir Medical Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
St. Helena Hospital
City
Deer Park
State/Province
California
ZIP/Postal Code
94576
Country
United States
Facility Name
Cardiovascular Consultants Heart Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Newport Diagnostic Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Pro Health Advance Imaging
City
North Hollywood
State/Province
California
ZIP/Postal Code
91602
Country
United States
Facility Name
Eisenhower Medical Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
St. Mary's Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Sansum Clinic - Santa Barbara Medical Foundation
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
South Denver Cardiology Associates PC
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Cardiac Arrhythmia Services
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33422
Country
United States
Facility Name
Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Piedmont Athens Regional Medical Center
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
Advocate Lutheran General Hospital
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Community Heart and Vascular
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
King's Daughters Medical Center
City
Ashland
State/Province
Kentucky
ZIP/Postal Code
25704
Country
United States
Facility Name
LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Suburban Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
McLaren Health Care Corporation
City
Auburn Hills
State/Province
Michigan
ZIP/Postal Code
48326
Country
United States
Facility Name
Baptist Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Advanced Radiology
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Kearney Regional Medical Center
City
Kearney
State/Province
Nebraska
ZIP/Postal Code
68845
Country
United States
Facility Name
Denville Diagnostics and Open MRI LLC
City
Denville
State/Province
New Jersey
ZIP/Postal Code
07834
Country
United States
Facility Name
Borg and Ide Imaging
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Novant Clinical Research Institute
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Samaritan Heart & Vascular Institute - Cardiology Dept.
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Oregon Medical Group
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Lehigh Valley Hospital - 17th Street
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
19118
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2150
Country
United States
Facility Name
St. Mary Medical Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Allegheny Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Donald Guthrie Foundation for Education and Research
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Trident Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Erlanger Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Baylor All Saints Medical Center at Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
East Texas Medical Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Lynchburg General Hospital
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Overlake Hospital Medical Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Swedish Medical Center - Heart & Vascular
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Aurora Medical Group
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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SJM MRI Diagnostic Imaging Registry (IDE)
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