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

This study has been completed.
Sponsor:
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00848653
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • to track all programming changes made to the LV pacing/sensing configurations [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00848653

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

No publications provided by Guidant Corporation

Additional 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
Study First Received: February 19, 2009
Last Updated: February 19, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014