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

Overview

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.

Full Title of Study: “Cardiac Resynchronization Therapy (CRT) in the Early Phase After Heart Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

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

  • Procedure: Temporary cardiac resynchronization therapy

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Overall Official(s)
    • Jesper H Svendsen, MD, Principal Investigator, Rigshospitalet, Denmark

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