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

Arrhythmia Clinical Trial

Official title:

ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146822
• Other study ID #: CR-CA-022504-L
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2005
• Last updated: February 2, 2017
• Start date: February 2004
• Est. completion date: March 2006

Study information

• Verified date: February 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia

Intervention

Device:
• ENDOTAK RELIANCE G lead

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lead electrical properties
Primary	First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation
Secondary	Lead handling characteristics
Secondary	Lead migration/dislodgment rates
Secondary	Characterize the current ICD/CRT-D population
Secondary	Effects of ischemia and revascularization and previous lead extraction on the lead's electrical performance