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Completed

NCT Number: NCT00146822

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

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.

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENDOTAK RELIANCE G lead

Device

Primary outcomes

  1. Lead electrical properties

  2. First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance Study

Important dates

Study start
2004
Study completion
2006
First posted
Sep 7, 2005
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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