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This study is designed to collect high-quality shoulder and intracardiac bi-plane fluoroscopic images during two standard arm motions on patients implanted with a market released SelectSecure 3830 lead for the purposes of developing a fracture reliability model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects undergoing bi-plane fluoroscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bi-plane fluoroscopy | Diagnostic Test | In vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead. | Fluoroscopic cine images will be collected in conjunction with a specialized calibration object. When imaging data is processed and analyzed it will characterize the time-varying lead shape changes. | approximately 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Acquire accelerometer-based motion data | During fluoroscopy of the two standard arm motions, accelerometer-based motion data will be collected which will allow matching of arm position with lead shape based on the fluoroscopic images. | approximately 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects of both genders, 18 years of age and older that are currently implanted with at least one SelectSecure 3830 lead, regardless of device type and who meet all inclusion and no exclusion criteria are eligible for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research | Huntsville | Alabama | 35801 | United States | ||
| Iowa Heart Center |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| West Des Moines |
| Iowa |
| 50266 |
| United States |
| Associates in Cardiology PA | Silver Spring | Maryland | 20910 | United States |
| Lourdes Cardiology Services | Voorhees Township | New Jersey | 08043 | United States |