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The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.
This is a prospective, multi-center clinical study is to evaluate the safety and effectiveness of the EASYTRAK 4 STEERABLE LV lead.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EASYTRAK 4 STEERABLE LV lead | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Lead-related complication free-rate at 3-months. | ||
| Chronic mean pacing thresholds at 3-months. |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic Mean pacing impedances at 3-months | ||
| Chronic Mean R-wave amplitudes at 3-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Mester, MD | Tampa General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple locations | Saint Paul | Minnesota | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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