Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00417092

Enrollment

100

Registered

2006-12-29

Start date

2006-12-31

Completion date

2007-09-30

Last updated

2007-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

coronary artery bypass grafting, reduced left ventricular function, postoperative pacing, cardiac resynchronization

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.

Interventions

PROCEDUREPostoperative Pacing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Duration of Intensive Care Treatment	—

Secondary

Measure	Time frame
Major adverse events	—
Duration of Hospital Stay	—
Hemodynamic parameters	—
Inotrope use	—
30 day mortality	—
Ventricular tachycardia / ventricular fibrillation	—
Renal function	—
Stability of pacing wires	—
Atrial fibrillation	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026