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The primary objective of this clinical investigation is to evaluate the safety and effectiveness of the EASYTRAK 3 Downsize Lead.
This is a prospective, non-randomized, multi-center US clinical investigation, designed to demonstrate the safety and effectiveness of the Guidant EASYTRAK 3 Downsize Lead in humans.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EASYTRAK 3 Downsize Lead | Device | EASYTRAK 3 Downsize Lead |
| Measure | Description | Time Frame |
|---|---|---|
| Lead-related complication-free rate at one-month | 1 month | |
| Chronic mean pacing thresholds at one-month. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Chronic mean R-wave amplitudes at one-month | 1 month | |
| Chronic mean pacing impedances at one-month. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Hummel, MD | Riverside Methodist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Saint Paul | Minnesota | 55112 | United States |
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| Label | URL |
|---|---|
| Heart Failure | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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