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

Sponsored by:	St. Michael's Hospital, Toronto
Information provided by:	St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:	NCT00316368

Purpose

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.

Condition	Intervention	Phase
Coronary Disease	Device: Ethicon TPW32 60 cm (pacing wires x 2)	Phase I

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease

U.S. FDA Resources

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

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:

Cardiac index

Secondary Outcome Measures:

Intraventricular motion

Estimated Enrollment:	60
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316368

Contacts

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

Locations

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

Sponsors and Collaborators

St. Michael's Hospital, Toronto

Investigators

Principal Investigator:

David Latter, MD

University of Toronto

More Information

Study ID Numbers:	05-318
Study First Received:	April 18, 2006
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00316368
Health Authority:	Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:

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

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009