Arrhythmia
Conditions
Brief summary
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.
Interventions
DEVICEENDOTAK RELIANCE G lead
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lead electrical properties | — |
| First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation | — |
Secondary
| Measure | 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 | — |
Outcome results
None listed