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

2014-07-23 21:45:15 | BioPortfolio

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.

Study Design

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

Conditions

Coronary Disease

Intervention

Ethicon TPW32 60 cm (pacing wires x 2)

Location

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

Status

Completed

Source

St. Michael's Hospital, Toronto

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:45:15-0400

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