REFLEx Study (ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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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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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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