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

Guidant Corporation260 enrolled

Overview

The ELECtrode configuraTION CRT Study (ELECTION)

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 Type

OBSERVATIONAL

Enrollment

260

Conditions

Heart Failure

Interventions

CRT deviceDEVICE

market approved CRT device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

to test and compare all available LV pacing and sensing configurations

Time frame: 6 months

Secondary Outcomes

to track all programming changes made to the LV pacing/sensing configurations

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.