Multisite Pacing With a Quadripolar Lead

Abbott

Status and phase

Completed

Phase 4

Conditions

Heart Failure

Treatments

Device: Quadripolar LV lead (pacing configurations)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00964938

MSLV

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of multisite left ventricular (LV) biventricular (BiV) pacing on LV hemodynamics in CRT patients. It is hypothesized that the effect of simultaneous BiV pacing utilizing multisite LV pacing on LV hemodynamics will be superior to conventional BiV pacing.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have a scheduled CRT implantation at the participating clinical study site
Have NYHA functional class III or IV, ejection fraction less than or equal to 35%, and QRS duration greater than 120ms
Be undergoing a new St. Jude Medical CRT-D device system (including LV lead) implantation
Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed perioperative evaluations

Exclusion criteria

Have persistent or permanent atrial fibrillation
Have an intrinsic heart rate of <50 beats per minute
Have a recent myocardial infarction within 40 days prior to enrollment
Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
Have had a recent CVA or TIA within 3 months prior to enrollment
Have had intravenous inotropic support in the last 30 days
Have ischemic etiology and are unable to tolerate stress echocardiography