Heart FailureELECTIONNCT00848653
ELECTION - The Electrode Configuration Cardiac Resynchronization Therapy (CRT) Study (ELECTION)
An observational study of Heart Failure, run by Guidant Corporation.
Trial summary
The ELECtrode configuraTION CRT Study (ELECTION) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT device
- Type of treatment
- Medical device
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Dec 2008
- 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: patients indicated for CRT therapy
Who may be able to join
- Patients selected for a Guidant system, symptomatic heart failure, LV dysfunction, QRS width > 120 ms, > or = 18 yrs, able to understand the procedure, available for follow-up.
Who cannot join
- < 18 years, life expectancy < 6 months, expectation of heart transplantation during the study period, patients who have or are likely to receive a mechanical tricuspid valve, documented aortic stenosis, hypertrophic obstructive cardiomyopathy, inability or refusal to complete the follow-up at an approved centre, enrollment in another cardiovascular clinical investigation unless approved by the Manager of Clinical Studies, Guidant Canada, inability or refusal to sign consent.
About this study
Official title: The Electrode Configuration (ELECTION) CRT Study Including ELECTION Phrenic Nerve Stimulation (PNS) Sub-Study
The ELECtrode configuraTION CRT Study (ELECTION)
Read the detailed description
Cardiac resynchronization therapy (CRT) is an accepted treatment for selected heart failure patients. This therapy is delivered using a device (pacemaker (PM) +/- defibrillator (ICD) ) and leads placed in the right atrium (RA), right ventricle (RV) and left ventricle (LV). Rates of LV lead implantation failure and post operative lead related have decreased dramatically over the years, however, the incidence of lead dislodgement and phrenic nerve stimulation is still high. This study is a prospective evaluation of the benefits of having various pace/sense electrode configurations available in a CRT system.
- Conditions
- Heart Failure
- Being tested
- CRT device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT deviceDevice
market approved CRT device
What is being measured
The primary outcome is the main question the study is designed to answer.
to test and compare all available LV pacing and sensing configurations
Measured: 6 months
Secondary outcomes (1)
to track all programming changes made to the LV pacing/sensing configurations
Measured: 6 months
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 startNov 2004
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guidant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean Champagne, MD, Principal investigator, Hopital Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848653
- Sponsor's protocol ID
- ELECTION
- Acronym
- ELECTION
- Status last verified
- Feb 2009
- First submitted
- 19 Feb 2009
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Champagne J, Healey JS, Krahn AD, Philippon F, Gurevitz O, Swearingen A, Glikson M; ELECTION Investigators. The effect of electronic repositioning on left ventricular pacing and phrenic nerve stimulation. Europace. 2011 Mar;13(3):409-15. doi: 10.1093/europace/euq499. Epub 2011 Jan 26.
PubMed 21273196
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Electrode Configuration (ELECTION) CRT Study Including ELECTION Phrenic Nerve Stimulation (PNS) Sub-Study
- ClinicalTrials.gov ID
- NCT00848653
- Acronym / sponsor ID
- ELECTION / ELECTION
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Guidant CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (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.
The ELECtrode configuraTION CRT Study (ELECTION)
Detailed description
Cardiac resynchronization therapy (CRT) is an accepted treatment for selected heart failure patients. This therapy is delivered using a device (pacemaker (PM) +/- defibrillator (ICD) ) and leads placed in the right atrium (RA), right ventricle (RV) and left ventricle (LV). Rates of LV lead implantation failure and post operative lead related have decreased dramatically over the years, however, the incidence of lead dislodgement and phrenic nerve stimulation is still high. This study is a prospective evaluation of the benefits of having various pace/sense electrode configurations available in a CRT system.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients indicated for CRT therapy
Key inclusion criteria (1 listed)
- Patients selected for a Guidant system, symptomatic heart failure, LV dysfunction, QRS width > 120 ms, > or = 18 yrs, able to understand the procedure, available for follow-up.
Key exclusion criteria (1 listed)
- < 18 years, life expectancy < 6 months, expectation of heart transplantation during the study period, patients who have or are likely to receive a mechanical tricuspid valve, documented aortic stenosis, hypertrophic obstructive cardiomyopathy, inability or refusal to complete the follow-up at an approved centre, enrollment in another cardiovascular clinical investigation unless approved by the Manager of Clinical Studies, Guidant Canada, inability or refusal to sign consent.
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 |
|---|---|---|
| CRT devicemarket approved CRT device | Device | – |
Primary outcome
to test and compare all available LV pacing and sensing configurations
Time frame: 6 months
1 secondary outcome
to track all programming changes made to the LV pacing/sensing configurations
Time frame: 6 months
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 20 Feb 2009.
- Derived from this study: PubMed 21273196Champagne J, Healey JS, Krahn AD, Philippon F, Gurevitz O, Swearingen A, Glikson M; ELECTION Investigators. The effect of electronic repositioning on left ventricular pacing and phrenic nerve stimulation. Europace. 2011 Mar;13(3):409-15. doi: 10.1093/europace/euq499. Epub 2011 Jan 26.
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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.
Jean Champagne, MD principal investigator
Hopital Laval
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, 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 20 Feb 2009. 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.
What does the primary outcome measure?
to test and compare all available LV pacing and sensing configurations (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00848653, which also lists 1 linked publication.
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 20 Feb 2009; AzTrials last refreshed its copy on 30 Oct 2026.