The CRT-KIR Study (Cardiac Resynchronization Therapy [CRT] in the Early Phase After Heart Surgery)

Not Applicable

Withdrawn

• Conditions: Bundle-Branch Block

• Registration Number: NCT00192946
• Lead Sponsor: Rigshospitalet, Denmark

Brief Summary

In patients with broad QRS complexes on electrocardiogram (ECG), the delayed electrical activation of the left heart chamber will cause abnormal contraction.This has been shown to be possible to treat by a special pacemaker treatment which includes pacing of the left heart chamber (= CRT treatment).

In this study the researchers will investigate the effect of acute CRT treatment in the early phase after open heart surgery.

Detailed Description

Patients with bundle branch block have a delayed electrical activation of the left ventricle causing abnormal contractility of the left ventricle.

We hypothesize that patients may benefit from short term (= 72 hours) CRT (Cardiac Resynchronization Therapy) in the early phase after open heart surgery.

Patients: reduced LV function and bundle branch block.

Study type: randomisation to CRT versus standard postoperative treatment

Study variables: cardiac output, echocardiographic measures, p-BNP and hours with inotropic therapy.

Study Timeline

• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-19
• Status Verified: 2006-02
• Last Update Submitted: 2007-07-09
• Last Update Posted: 2007-07-10
• Study Completion: 2008-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient scheduled for open heart surgery (coronary artery bypass graft [CABG] or mitral valve surgery or aortic valve surgery or combinations of the above mentioned surgical procedures) and LV ejection fraction < 35% and bundle branch block (QRS > 9.12 s)

Exclusion Criteria

• Severe right heart failure
• Permanent atrial fibrillation
• Congenital heart disease
• Serious non-cardiac disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Non invasive cardiac output after 72 hours CRT (versus control) treatment

Secondary Outcome Measures

Name	Time	Method
Echocardiographic measures of left ventricular (LV) function
Mixed venous oxygen saturation
Invasively determined cardiac output
Plasma brain natriuretic peptide (p-BNP)
Number of hours with inotropic treatment