NCT00316368

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

December 23, 2009

Status Verified

December 1, 2009

First QC Date

April 18, 2006

Last Update Submit

December 22, 2009

Conditions

Coronary Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Cardiac index

Secondary Outcomes (1)

  • Intraventricular motion

Interventions

Ethicon TPW32 60 cm (pacing wires x 2)DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • David Latter, MD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

October 1, 2006

Study Completion

October 1, 2008

Last Updated

December 23, 2009

Record last verified: 2009-12

Locations

CA(1)