NCT00848653

Brief Summary

The ELECtrode configuraTION CRT Study (ELECTION)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2004

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
Last Updated

February 20, 2009

Status Verified

February 1, 2009

Enrollment Period

3.8 years

First QC Date

February 19, 2009

Last Update Submit

February 19, 2009

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • to test and compare all available LV pacing and sensing configurations

    6 months

Secondary Outcomes (1)

  • to track all programming changes made to the LV pacing/sensing configurations

    6 months

Interventions

CRT deviceDEVICE

market approved CRT device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients indicated for CRT therapy

You may qualify if:

  • 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.

You may not qualify if:

  • \< 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21273196DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jean Champagne, MD

    Hopital Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

November 1, 2004

Primary Completion

September 1, 2008

Study Completion

December 1, 2008

Last Updated

February 20, 2009

Record last verified: 2009-02