Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)

Not Applicable

Completed

• Conditions: Cardiac Pacing,Artificial; Coronary Artery Bypass; Ventricular Function, Left

• Registration Number: NCT00417092
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-28
• Study First Submitted QC: 2006-12-28
• Study First Posted: 2006-12-29
• Status Verified: 2007-09
• Study Completion: 2007-09
• Last Update Submitted: 2007-09-21
• Last Update Posted: 2007-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of Intensive Care Treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Schleswig Holstein, Campus Luebeck, Cardiac Surgery; 🇩🇪 Luebeck, Schleswig Holstein, Germany