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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00848653
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : February 20, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The ELECtrode configuraTION CRT Study (ELECTION)

Condition or disease Intervention/treatment Phase
Heart Failure Device: CRT device Phase 4

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

Study Type : Observational
Actual Enrollment : 260 participants
Time Perspective: Prospective
Official Title: The Electrode Configuration (ELECTION) CRT Study Including ELECTION Phrenic Nerve Stimulation (PNS) Sub-Study
Study Start Date : November 2004
Primary Completion Date : September 2008
Study Completion Date : December 2008
Groups and Cohorts

Intervention Details:
    Device: CRT device
    market approved CRT device

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848653


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne Swearingen, Guidant
ClinicalTrials.gov Identifier: NCT00848653     History of Changes
Other Study ID Numbers: ELECTION
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: February 20, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases