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The REFLEx Study will evaluate if ENDOTAK RELIANCE G defibrillation leads with GORE ePTFE-covered coils are as good as or better than other comparative commercially available defibrillation leads with respect to electrical performance and termination efficacy in spontaneous tachyarrhythmic episodes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDOTAK RELIANCE G lead | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Lead electrical properties | ||
| First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation |
| Measure | Description | Time Frame |
|---|---|---|
| Lead handling characteristics | ||
| Lead migration/dislodgment rates | ||
| Characterize the current ICD/CRT-D population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randolph Cooper, MD | Wake Heart Associates | Principal Investigator |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Effects of ischemia and revascularization and previous lead extraction on the lead's electrical performance |