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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00848653

Acronym

ELECTION

Enrollment

260

Registered

2009-02-20

Start date

2004-11-30

Completion date

2008-12-31

Last updated

2009-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief 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.

Interventions

DEVICECRT device

market approved CRT device

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
to test and compare all available LV pacing and sensing configurations	6 months

Secondary

Measure	Time frame
to track all programming changes made to the LV pacing/sensing configurations	6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026