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

NCT ID: NCT00146822

Last Updated: 2017-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-03-31

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.

Conditions

Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Interventions

ENDOTAK RELIANCE G lead

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Principal Investigators

Randolph Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Heart Associates

Other Identifiers

CR-CA-022504-L

Identifier Type: -

Identifier Source: org_study_id