Text Size

Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)

This study has been completed.
Sponsor:
Information provided by:
University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00417092
First received: December 28, 2006
Last updated: September 21, 2007
Last verified: September 2007
History of Changes

December 28, 2006
September 21, 2007
December 2006
Not Provided
Duration of Intensive Care Treatment
Same as current
Complete list of historical versions of study NCT00417092 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)
Not Provided

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Cardiac Pacing,Artificial
  • Coronary Artery Bypass
  • Ventricular Function, Left
Procedure: Postoperative Pacing
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00417092
UL 04-156
Not Provided
Not Provided
University of Schleswig-Holstein
Not Provided
Study Director: Uwe KH Wiegand, MD University Hospital Schlesig Holstein, Campus Luebeck, Medicine II, Luebeck, Germany
University of Schleswig-Holstein
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP