Biventricular Pacing After Coronary Artery Bypass Grafting (BIVAC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Cardiac Pacing,Artificial Coronary Artery Bypass Ventricular Function, Left

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Postoperative Pacing

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Uwe KH Wiegand, MD

Role: STUDY_DIRECTOR

University Hospital Schlesig Holstein, Campus Luebeck, Medicine II, Luebeck, Germany

Locations

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University Hospital Schleswig Holstein, Campus Luebeck, Cardiac Surgery

Lübeck, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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UL 04-156

Identifier Type: -

Identifier Source: org_study_id