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

This study has been completed.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00146822
First received: September 2, 2005
Last updated: November 13, 2006
Last verified: April 2006
  Purpose

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 Intervention Phase
Arrhythmia
Device: ENDOTAK RELIANCE G lead
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance Study

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 1500
Study Start Date: February 2004
Estimated Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146822

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

No publications provided

ClinicalTrials.gov Identifier: NCT00146822     History of Changes
Other Study ID Numbers: CR-CA-022504-L
Study First Received: September 2, 2005
Last Updated: November 13, 2006
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014