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Completed

NCT Number: NCT00316368

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

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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ethicon TPW32 60 cm (pacing wires x 2)

Device

Primary outcomes

  1. Cardiac index

Secondary outcomes

  1. Intraventricular motion

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Important dates

Study start
2006
Study completion
2008
First posted
Apr 20, 2006
Registry last updated
Dec 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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