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

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316368
• Other study ID #: 05-318
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2006
• Last updated: December 22, 2009
• Start date: October 2006
• Est. completion date: October 2008

Study information

• Verified date: December 2009
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• Ethicon TPW32 60 cm (pacing wires x 2)

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac index
Secondary	Intraventricular motion