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

December 22, 2009 updated by: Unity Health Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cardiac index

Secondary Outcome Measures

Outcome Measure
Intraventricular motion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: David Latter, MD, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

April 18, 2006

First Submitted That Met QC Criteria

April 18, 2006

First Posted (Estimate)

April 20, 2006

Study Record Updates

Last Update Posted (Estimate)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 22, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-318

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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