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CompletedNCT00848653

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

The Electrode Configuration (ELECTION) CRT Study Including ELECTION Phrenic Nerve Stimulation (PNS) Sub-Study

Status
Completed
Phase
Study type
Observational
Enrollment
260 (actual)
Sponsor
Guidant Corporation · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DEVICECRT devicemarket approved CRT device

Timeline

Start date
2004-11-01
Primary completion
2008-09-01
Completion
2008-12-01
First posted
2009-02-20
Last updated
2009-02-20

Source: ClinicalTrials.gov record NCT00848653. Inclusion in this directory is not an endorsement.

ELECTION - The Electrode Configuration Cardiac Resynchronization Therapy (CRT) Study (ELECTION) (NCT00848653) · Clinical Trials Directory