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The study is designed to collect data on Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details, and/or patient characteristics to support development of future CIED products and procedures.
This is a data collection, non-randomized, multi-center study. The study will consist of different cohorts with each cohort being independent from another cohort. Each cohort may have a distinct objective, cohort-specific subject population, procedures, and assessments. The study will follow subjects receiving routine care, who meet all of the inclusion criteria and none of the exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIED Indicated Subjects | Subjects indicated to receive a cardiac implantable electronic devices (CIEDs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiac implantable electronic devices (CIEDs) | Device | Subjects will be implanted with various cardiac implantable electronic devices and followed according to their standard of care. Medical imaging will be collected at various stages of the implant procedure and/or non-invasive diagnostic collection at follow-up visits, as applicable. |
| Measure | Description | Time Frame |
|---|---|---|
| Product Development | Characterize Cardiovascular Implantable Electronic Device (CIED) information, implant procedure details and/or patient characteristics to support development of future CIED products and procedures. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who meet all inclusion criteria and none of the exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cardiac & Vascular Institute | Gainesville | Florida | 32605 | United States | ||
| Georgia Arrhythmia Consultants |
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|
| Macon |
| Georgia |
| 31201 |
| United States |
| Oregon Health & Science University Hospital | Portland | Oregon | 97239 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17604 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22903 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| UZ Leuven - Campus Gasthuisberg | Leuven | Belgium |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001919 | Bradycardia |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000075224 | Cardiac Conduction System Disease |
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