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Clinical Trials/NCT00417092
NCT00417092
Completed
Not Applicable

Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)

University Hospital Schleswig-Holstein1 site in 1 country100 target enrollmentDecember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Pacing,Artificial
Sponsor
University Hospital Schleswig-Holstein
Enrollment
100
Locations
1
Primary Endpoint
Duration of Intensive Care Treatment
Status
Completed
Last Updated
18 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
September 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital Schleswig-Holstein

Eligibility 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

Outcomes

Primary Outcomes

Duration of Intensive Care Treatment

Secondary Outcomes

  • 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

Study Sites (1)

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