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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00417092     History of Changes
Other Study ID Numbers: UL 04-156
Study First Received: December 28, 2006
Last Updated: September 21, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 01, 2014