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Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00417092
First Posted: December 29, 2006
Last Update Posted: September 24, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Schleswig-Holstein
  Purpose
The purpose of this study is to determine which pacing mode after coronary artery bypass grafting in patients with reduced left ventricular function is hemodynamically favorable.

Condition Intervention
Cardiac Pacing,Artificial Coronary Artery Bypass Ventricular Function, Left Procedure: Postoperative Pacing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • Duration of Intensive Care Treatment

Secondary Outcome Measures:
  • 30 day mortality
  • Major adverse events
  • Duration of Hospital Stay
  • Hemodynamic parameters
  • Inotrope use
  • Atrial fibrillation
  • Ventricular tachycardia / ventricular fibrillation
  • Renal function
  • Stability of pacing wires

Estimated Enrollment: 100
Study Start Date: December 2006
Study Completion Date: September 2007
Detailed Description:
Patients with severely reduced left ventricular function undergoing coronary artery bypass grafting (CABG) are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious whereas biventricular pacing improves cardiac output in patients with severely reduced left ventricular function and bundle branch block. The purpose of this study is to compare DDD-right ventricular, DDD-biventricular and AAI pacing in CABG patients with an ejection fraction less than 40% in a prospective randomized setting.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective or urgent coronary artery bypass grafting
  • Preoperative ejection fraction less than 40%

Exclusion Criteria:

  • Existing permanent pacemaker or ICD
  • Concomitant valve surgery
  • Preoperative cardiovascular instability requiring intubation or IABP use
  • Chronic renal failure requiring dialysis
  • Failure to provide informed consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00417092


Locations
Germany
University Hospital Schleswig Holstein, Campus Luebeck, Cardiac Surgery
Luebeck, Schleswig Holstein, Germany, 23538
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Study Director: Uwe KH Wiegand, MD University Hospital Schlesig Holstein, Campus Luebeck, Medicine II, Luebeck, Germany
  More Information

ClinicalTrials.gov Identifier: NCT00417092     History of Changes
Other Study ID Numbers: UL 04-156
First Submitted: December 28, 2006
First Posted: December 29, 2006
Last Update Posted: September 24, 2007
Last Verified: September 2007

Keywords provided by University of Schleswig-Holstein:
coronary artery bypass grafting
reduced left ventricular function
postoperative pacing
cardiac resynchronization