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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. Read our disclaimer for details. Identifier: NCT00146822
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : February 6, 2017
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Arrhythmia Device: ENDOTAK RELIANCE G lead Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance Study
Study Start Date : February 2004
Study Completion Date : March 2006

Primary Outcome Measures :
  1. Lead electrical properties
  2. First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation

Secondary Outcome Measures :
  1. Lead handling characteristics
  2. Lead migration/dislodgment rates
  3. Characterize the current ICD/CRT-D population
  4. Effects of ischemia and revascularization and previous lead extraction on the lead's electrical performance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00146822

Sponsors and Collaborators
Boston Scientific Corporation
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Principal Investigator: Randolph Cooper, MD Wake Heart Associates

Layout table for additonal information Identifier: NCT00146822     History of Changes
Other Study ID Numbers: CR-CA-022504-L
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017