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

Phase 4

Completed

• Conditions: Arrhythmia

• Registration Number: NCT00146822
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-07
• Study Completion: 2006-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lead electrical properties
First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation

Secondary Outcome Measures

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