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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00417092
Other study ID # UL 04-156
Secondary ID
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
Est. primary completion date
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


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
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