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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00192946
Enrollment
60
Registered
2005-09-19
Start date
Unknown
Completion date
2008-09-30
Last updated
2007-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bundle-Branch Block

Keywords

Cardiac resynchronization, Heart failure, open heart surgery, surgery

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.

Interventions

PROCEDURETemporary cardiac resynchronization therapy

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Non invasive cardiac output after 72 hours CRT (versus control) treatment

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026