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Sponsored by: |
St. Michael's Hospital, Toronto |
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Information provided by: | St. Michael's Hospital, Toronto |
ClinicalTrials.gov Identifier: | NCT00316368 |
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:
Secondary Hypothesis:
Condition | Intervention | Phase |
---|---|---|
Coronary Disease |
Device: Ethicon TPW32 60 cm (pacing wires x 2) |
Phase I |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass Graft |
Estimated Enrollment: | 60 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
High inotrope dosage post-operation:
Contact: David Latter, MD | 1-416-864-5366 | latterd@smh.toronto.on.ca |
Contact: Hosam Fawzy, MD | 416-864-6060 ext 3289 | hosamfawzy@hotmail.com |
Canada, Ontario | |
St. Michael's Hospital | Recruiting |
Toronto, Ontario, Canada, M5B 1W8 | |
Contact: Hosam Fawzy, MD 1-416-864-6060 ext 3289 hosamfawzy@hotmail.com | |
Principal Investigator: David Latter, MD | |
Sub-Investigator: Hosam Fawzy, MD | |
Sub-Investigator: Mary Keith, PhD | |
Sub-Investigator: Daniel Bonneau, MD | |
Sub-Investigator: Lee Errett, MD | |
Sub-Investigator: Stuart Hutchison, MD | |
Sub-Investigator: Arnold Pinter, MD |
Principal Investigator: | David Latter, MD | University of Toronto |
Study ID Numbers: | 05-318 |
Study First Received: | April 18, 2006 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00316368 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Bi-Ventricular pacing post coronary artery bypass graft coronary artery bypass graft |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease |