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

February 2, 2017 updated by: Boston Scientific Corporation

ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1500

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Lead electrical properties
First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Randolph Cooper, MD, Wake Heart Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-CA-022504-L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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