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The purpose of this Post-Approval Study (PAS) is to demonstrate the chronic performance of the SureScan pacing system when used in an MRI environment according to product labeling. This study is required by the Food and Drug Administration (FDA) as a condition of product approval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Performance | Subjects enrolled prior to or within 30 days post implant of SureScan pacing system. In office follow-up visits required every 6 months. | ||
| Multiple MRI Scan Characterization | Subject enrolled into study at the time of MRI Scan indication. Subject followed per clinic standard of care. |
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| Measure | Description | Time Frame |
|---|---|---|
| MRI Related Complication Rate | 5 years | |
| Lead Related Complication Rate | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assess change in pacing thresholds after multiple MRI scans | 5 years | |
| Summarize MRI system and scan conditions | 5 years | |
| Pacing system related events |
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Inclusion Criteria:
Exclusion Criteria:
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Patients indicated for or implanted with a Medtronic SureScan Pacing System. All subjects must meet Inclusion criteria and none of the Exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29759618 | Derived | Williamson BD, Gohn DC, Ramza BM, Singh B, Zhong Y, Li S, Shanahan L; SureScan Post-Approval Study Investigators. Real-World Evaluation of Magnetic Resonance Imaging in Patients With a Magnetic Resonance Imaging Conditional Pacemaker System: Results of 4-Year Prospective Follow-Up in 2,629 Patients. JACC Clin Electrophysiol. 2017 Nov;3(11):1231-1239. doi: 10.1016/j.jacep.2017.05.011. Epub 2017 Sep 13. |
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| 5 years |
| Characterize lead impedance | 5 years |
| Bakersfield |
| California |
| United States |
| Chula Vista | California | United States |
| East Palo Alto | California | United States |
| Fresno | California | United States |
| Glendale | California | United States |
| Long Beach | California | United States |
| Los Angeles | California | United States |
| Salinas | California | United States |
| Santa Rosa | California | United States |
| Torrance | California | United States |
| Van Nuys | California | United States |
| Colorado Springs | Colorado | United States |
| New Haven | Connecticut | United States |
| Bradenton | Florida | United States |
| Clearwater | Florida | United States |
| Fort Lauderdale | Florida | United States |
| Atlanta | Georgia | United States |
| Urbana | Illinois | United States |
| Evansville | Indiana | United States |
| West Des Moines | Iowa | United States |
| Kansas City | Kansas | United States |
| Louisville | Kentucky | United States |
| Salisbury | Maryland | United States |
| Takoma Park | Maryland | United States |
| Marquette | Michigan | United States |
| Troy | Michigan | United States |
| Coon Rapids | Minnesota | United States |
| Robbinsdale | Minnesota | United States |
| Saint Louis Park | Minnesota | United States |
| Saint Paul | Minnesota | United States |
| Kansas City | Missouri | United States |
| Henderson | Nevada | United States |
| West Orange | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Huntington | New York | United States |
| New York | New York | United States |
| Durham | North Carolina | United States |
| Hickory | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Akron | Ohio | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Elyria | Ohio | United States |
| Toledo | Ohio | United States |
| Bethlehem | Pennsylvania | United States |
| Erie | Pennsylvania | United States |
| Lancaster | Pennsylvania | United States |
| Wyomissing | Pennsylvania | United States |
| Florence | South Carolina | United States |
| Nashville | Tennessee | United States |
| Dallas | Texas | United States |
| Fort Sam Houston | Texas | United States |
| Fort Worth | Texas | United States |
| San Antonio | Texas | United States |
| Falls Church | Virginia | United States |
| Milwaukee | Wisconsin | United States |
| Kingston | Ontario | Canada |
| Trois-Rivières | Quebec | Canada |
| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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