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

Bundle-Branch Block Clinical Trial

Official title:

Cardiac Resynchronization Therapy (CRT) in the Early Phase After Heart Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00192946
• Other study ID #: KF 01-230/04
• Status: Withdrawn
• Phase: N/A
• First received: September 11, 2005
• Last updated: July 9, 2007
• Est. completion date: September 2008

Study information

• Verified date: February 2006
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 60
• Est. completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bundle-Branch Block

Intervention

Procedure:
• Temporary cardiac resynchronization therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non invasive cardiac output after 72 hours CRT (versus control) treatment
Secondary	Echocardiographic measures of left ventricular (LV) function
Secondary	Mixed venous oxygen saturation
Secondary	Invasively determined cardiac output
Secondary	Plasma brain natriuretic peptide (p-BNP)
Secondary	Number of hours with inotropic treatment