Multisite Pacing With a Quadripolar Lead

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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Quadripolar LV lead (pacing configurations)

Quadripolar LV lead will be used to deliver a combination of pacing configurations

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No