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

Guidant

Status: Completed

Conditions: Heart Failure

Treatments: Device: CRT device

Study type: Observational

Funder types: Industry

Identifiers

NCT00848653

ELECTION

Details and patient eligibility

About

The ELECtrode configuraTION CRT Study (ELECTION)

Full 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.

Enrollment: 260 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.