This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

ELECTION - The Electrode Configuration Cardiac Resynchronization Therapy (CRT) Study (ELECTION) (ELECTION)

This study has been completed.
Information provided by:
Guidant Corporation Identifier:
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
The ELECtrode configuraTION CRT Study (ELECTION)

Condition Intervention Phase
Heart Failure Device: CRT device Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Electrode Configuration (ELECTION) CRT Study Including ELECTION Phrenic Nerve Stimulation (PNS) Sub-Study

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:
  • to test and compare all available LV pacing and sensing configurations [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • to track all programming changes made to the LV pacing/sensing configurations [ Time Frame: 6 months ]

Enrollment: 260
Study Start Date: November 2004
Study Completion Date: December 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CRT device
    market approved CRT device
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients indicated for CRT therapy

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • < 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00848653

Sponsors and Collaborators
Guidant Corporation
Principal Investigator: Jean Champagne, MD Hopital Laval
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anne Swearingen, Guidant Identifier: NCT00848653     History of Changes
Other Study ID Numbers: ELECTION
Study First Received: February 19, 2009
Last Updated: February 19, 2009

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on June 23, 2017