A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass Graft

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

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-10-31

Brief Summary

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The purpose of this study is to determine, using echocardiography, whether bi-ventricular pacing improves the contractile force by resynchronizing both ventricles, thereby improving and/or correcting the paradoxical septal movement.

Primary Hypothesis:

* Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in cardiac index (CI) as compared with standard atrio-right ventricular pacing.

Secondary Hypothesis:

* Bi-ventricular pacing post cardiac surgery will result in at least a 10% increase in cardiac index (CI) as compared with atrio-left ventricular pacing and right atrium pacing.

Detailed Description

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Clinical trials done to date have focused on the efficacy of biventricular pacing (BVP) in the treatment of patients with congestive heart failure, Intraventricular conduction delay, dilated cardiomyopathies, and post cardiac surgery. However, studies done in post cardiac surgery patients are limited by their small sample size (4-22 patients with overall of 51 patients), non-randomized pacing protocol and by their inability to determine a definitive mechanism for the improved hemodynamics observed with BVP. Therefore, we propose to complete a pilot study aimed at determining both the magnitude of the hemodynamic benefit associated with BVP, if any. In addition, we will investigate changes in intra-ventricular septal motion as a possible mechanism for the previously observed changes in cardiac hemodynamics.

Conditions

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Coronary Disease

Keywords

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Bi-Ventricular pacing post coronary artery bypass graft coronary artery bypass graft

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

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Ethicon TPW32 60 cm (pacing wires x 2)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All elective/emergent patients requiring isolated coronary artery bypass graft (CABG) at St. Michael's Hospital.

Exclusion Criteria

* Patient's age \< 18 years.
* Known atrial fibrillation.
* Sinus tachycardia \> 100 beats per minute (bpm).
* Post-operative CI \< 2.
* High inotrope dosage post-operation:

* Dopamine (Intropin) if \> 10 µg/kg/min.
* Dobutamine (Dobutrex) if \> 10 µg/kg/min.
* Norepinephrine (Levophed) if \> 0.1 µg/kg/min.
* Epinephrine if \> 0.1 µg/kg/min.
* Need for intraaortic balloon pump (IABP).
* Unable or unwilling to give informed consent.
* Already participating in another clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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David Latter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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05-318

Identifier Type: -

Identifier Source: org_study_id