Status:
COMPLETED
REFLEx Study (ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00146822
Start Date
February 1 2004
End Date
March 1 2006
Last Update
February 6 2017
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