Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316368
Status:
COMPLETED
Last Update Posted:
2009-12-23
First Post:
2006-04-18
Brief Title:
A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass Graft
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass Graft
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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:
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None