REFLEx Study (ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance

Study Overview
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Brief Summary
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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.

Official Title
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ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance Study

Conditions
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Arrhythmia

Intervention / Treatment
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* Device: ENDOTAK RELIANCE G lead


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who meet current ICD or CRT-D indications Patients who are going to be implanted with one of the aforementioned ICD or CRT-D devices Patients who are going to be implanted with active-fixation, dual-coil, endocardial defibrillation leads with compatible connectors (i.e., ENDOTAK RELIANCE G or study-comparative ICD leads) Patients who sign and date a Patient Informed Consent form prior to device implant Patients who remain in the clinical care of the enrolling physician in approved centers Patients who are at least 18 years old Exclusion Criteria: Patients who have a preexisting transvenous lead system that is not completely explanted Patients who are hypersensitive to a single dose of approximately 1.0 mg of dexamethasone acetate Patients who are expected to receive a heart transplant during the duration of the study Patients whose estimated life expectancy is less than 12 months due to other medical conditions Patients who currently have or who are likely to receive a tricuspid valve prosthesis Patients who are likely to have an open-chest surgery in the next three months Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the REFLEx study. Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study Patients who are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ENDOTAK RELIANCE G lead|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead electrical properties |  |  | 
| First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lead handling characteristics |  |  | 
| Lead migration/dislodgment rates |  |  | 
| Characterize the current ICD/CRT-D population |  |  | 
| Effects of ischemia and revascularization and previous lead extraction on the lead's electrical performance |  |  |