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OpenTrials
Completed

NCT Number: NCT00417092

Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)

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.

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Key information

Conditions

Cardiac Pacing,Artificial Coronary Artery Bypass Ventricular Function, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Schleswig Holstein, Campus Luebeck, Cardiac Surgery

Lübeck, Schleswig-Holstein, 23538, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative Pacing

Procedure

Primary outcomes

  1. Duration of Intensive Care Treatment

Secondary outcomes

  1. 30 day mortality

  2. Major adverse events

  3. Duration of Hospital Stay

  4. Hemodynamic parameters

  5. Inotrope use

  6. Atrial fibrillation

  7. Ventricular tachycardia / ventricular fibrillation

  8. Renal function

  9. Stability of pacing wires

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Dec 29, 2006
Registry last updated
Sep 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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