ArrhythmiaPhase 4NCT00146822
REFLEx Study (ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance
A Phase 4 study testing ENDOTAK RELIANCE G lead in people with Arrhythmia, run by Boston Scientific Corporation.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- ENDOTAK RELIANCE G lead
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Mar 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
Official title: 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.
- Conditions
- Arrhythmia
- Being tested
- ENDOTAK RELIANCE G lead
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDOTAK RELIANCE G leadDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Lead electrical properties
First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation
Secondary outcomes (4)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Randolph Cooper, MD, Principal investigator, Wake Heart Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146822
- Sponsor's protocol ID
- CR-CA-022504-L
- Status last verified
- Feb 2017
- First submitted
- 2 Sep 2005
- Last updated
- 6 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENDOTAK RELIANCE G Evaluation of Handling and Electrical Performance Study
- ClinicalTrials.gov ID
- NCT00146822
- Acronym / sponsor ID
- CR-CA-022504-L
- Conditions
- Arrhythmia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Study completion
- Mar 2006
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDOTAK RELIANCE G lead | Device | – |
Primary outcome
Lead electrical properties
First shock conversion success rate for spontaneous fast ventricular tachycardia or ventricular fibrillation
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randolph Cooper, MD principal investigator
Wake Heart Associates
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ENDOTAK RELIANCE G lead in people with Arrhythmia, run by Boston Scientific Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lead electrical properties. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.