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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pacemaker, ICD, or CRT device patients | Other | Subjects who need a non-thoracic clinically indicated scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker, ICD, or CRT device | Device | MRI Scans on SJM device implanted subjects for clinical purpose |
|
| 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 |
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Inclusion Criteria:
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:
Patient has a lead extender, adaptor, or capped/abandoned lead
Patient is pregnant
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| Name | Affiliation | Role |
|---|---|---|
| Grant Kim | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Medical Imaging | Scottsdale | Arizona | 85258 | United States | ||
| University of Arizona |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pacemaker or CRT-P Device Patients | Subjects who need a non-thoracic clinically indicated scan Pacemaker or Cardiac Re-synchronization Therapy -Pacemaker (CRT-P) device: MRI Scans on SJM device implanted subjects for clinical purpose |
| FG001 | ICD or CRT-D Device Patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 15, 2017 |
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| 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 |
Subjects who need a non-thoracic clinically indicated scan Implantable Cardioverter Defibrillatoror (ICD) or a Cardiac Re-synchronization Therapy -Defibrillator (CRT-D) device: MRI Scans on SJM device implanted subjects for clinical purpose |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Arrhythmia History | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Proportion of MRI scans from CRT-Ps or Pacemakers providing sufficient image quality for diagnostic interpretation | Posted | Count of Units | MRI Scans | 1 month | MRI Scans | MRI Scans |
|
|
| ||||||||||||||||||||||||||
| Primary | 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. | Proportion of MRI scans from ICDs or CRT-Ds providing sufficient image quality for diagnostic interpretation | Posted | Count of Units | MRI Scans | 1 month | MRI Scans | MRI Scans |
|
|
Adverse events were collected from study enrollment until 1 month after the MRI scan was performed.
A Clinical Events Committee (CEC) composed of physicians who were not actively involved as investigators in any of the studies under the committee's review, nor may they have any significant financial interest in the technology under study, reviewed and adjudicated all adverse device effects, whether serious or not, and all deaths that were reported during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 189 | 0 | 189 | 4 | 189 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain/ Discomfort | General disorders | Systematic Assessment |
| ||
| Back-Up Operation | Cardiac disorders | Systematic Assessment | Device reset going into back up mode |
| |
| Respiratory Infection | Infections and infestations | Systematic Assessment | Respiratory infection reported a few days before MRI scan |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam M.Cline, MD, MSc.- Principal Scientist | Abbott | 818-493-2025 | adam.cline@abbott.com |
| Jul 26, 2018 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| C535598 | Creatine deficiency, X-linked |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| No Arrhythmia History |
|
| MRI Scans |
|
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