Multisite Pacing With a Quadripolar Left Heart Lead in Cardiovascular Resynchronization Therapy (CRT) Patients

Abbott Medical Devices1 site in 1 country35 target enrollmentAugust 2009

ConditionsHeart Failure

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Abbott Medical Devices
Enrollment: 35
Locations: 1
Primary Endpoint: dP/dt max
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2009

End Date

April 2011

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

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