Sudden Cardiac DeathLEAD LIFENCT00848835
Long Term Integrity Follow-up Evaluation
An observational study of Sudden Cardiac Death, run by Guidant Corporation.
Trial summary
To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads over 5 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death
- What is being tested?
- defibrillation lead (ENDOTAK EZ and RELIANCE)
- Type of treatment
- Medical device
- How many people
- 372 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Jan 2010
- Phase
- Observational
- 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
Study population: all patients who are indicated for a market released ICD
Who may be able to join
- Patients selected for Guidant ICD system implant, available for follow-up at the defined intervals
Who cannot join
- Patients enrolled in other studies, not available for follow-up, < 18 yrs, unable to sign consent, life expectancy < 1 year due to a medical condition
About this study
To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads over 5 years.
Read the detailed description
There are few prospective long term follow-up studies on implanted cardiac device (pacemaker/implantable cardioverter defibrillator (ICD)) survivability. This study will evaluate the long term performance (5 years) of the transvenous defibrillation leads (ENDOTAK ENDURANCE EZ and teh ENDOTAK RELIANCE. Data will be collected at implant, 1 and 6 months, 1,3 and 5 years.
- Conditions
- Sudden Cardiac Death
- Being tested
- defibrillation lead (ENDOTAK EZ and RELIANCE)
- Keywords
- defibrillator
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
defibrillation lead (ENDOTAK EZ and RELIANCE)Device
defibrillation lead
| Study group | Role | What they receive |
|---|---|---|
| control | all patients in the control group Receives: Device: defibrillation lead (ENDOTAK EZ and RELIANCE) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startMar 2002
- Primary completionOct 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guidant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lawrence Sterns, MD, Principal investigator, Victoria Cardiac Arrythmia trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848835
- Sponsor's protocol ID
- LEAD LIFE
- Acronym
- LEAD LIFE
- Status last verified
- Aug 2010
- First submitted
- 19 Feb 2009
- Last updated
- 31 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Integrity Follow-up Evaluation
- ClinicalTrials.gov ID
- NCT00848835
- Acronym / sponsor ID
- LEAD LIFE / LEAD LIFE
- Conditions
- Sudden Cardiac Death
- Keywords
- defibrillator
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Guidant CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Feb 2009 (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.
To document the performance of the Guidant ENDOTAK EZ and the RELIANCE defibrillation leads over 5 years.
Detailed description
There are few prospective long term follow-up studies on implanted cardiac device (pacemaker/implantable cardioverter defibrillator (ICD)) survivability. This study will evaluate the long term performance (5 years) of the transvenous defibrillation leads (ENDOTAK ENDURANCE EZ and teh ENDOTAK RELIANCE. Data will be collected at implant, 1 and 6 months, 1,3 and 5 years.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control | – | Device: defibrillation lead (ENDOTAK EZ and RELIANCE)all patients in the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients who are indicated for a market released ICD
Key inclusion criteria (1 listed)
- Patients selected for Guidant ICD system implant, available for follow-up at the defined intervals
Key exclusion criteria (1 listed)
- Patients enrolled in other studies, not available for follow-up, < 18 yrs, unable to sign consent, life expectancy < 1 year due to a medical condition
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 |
|---|---|---|
| defibrillation lead (ENDOTAK EZ and RELIANCE)defibrillation lead | Device | control |
Primary outcome
Not reported in the source record.
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 31 Aug 2010.
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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.
Lawrence Sterns, MD principal investigator
Victoria Cardiac Arrythmia trials
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death, run by Guidant 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 1 inclusion and 1 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 31 Aug 2010. 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.
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.
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 31 Aug 2010; AzTrials last refreshed its copy on 27 Oct 2026.