Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)

Coronary Artery Bypass Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417092
• Other study ID #: UL 04-156
• Status: Completed
• Phase: N/A
• First received: December 28, 2006
• Last updated: September 21, 2007
• Start date: December 2006
• Est. completion date: September 2007

Study information

• Verified date: September 2007
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Pacing,Artificial
• Coronary Artery Bypass
• Ventricular Function, Left

Intervention

Procedure:
• Postoperative Pacing

Locations

Country	Name	City	State
Germany	University Hospital Schleswig Holstein, Campus Luebeck, Cardiac Surgery	Luebeck	Schleswig Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Intensive Care Treatment
Secondary	30 day mortality
Secondary	Major adverse events
Secondary	Duration of Hospital Stay
Secondary	Hemodynamic parameters
Secondary	Inotrope use
Secondary	Atrial fibrillation
Secondary	Ventricular tachycardia / ventricular fibrillation
Secondary	Renal function
Secondary	Stability of pacing wires