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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00192946
Recruitment Status : Withdrawn (The study population is smaller than expected. No subjects were included.)
First Posted : September 19, 2005
Last Update Posted : July 10, 2007
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment
Bundle-Branch Block Procedure: Temporary cardiac resynchronization therapy

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cardiac Resynchronization Therapy (CRT) in the Early Phase After Heart Surgery
Estimated Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources




Primary Outcome Measures :
  1. Non invasive cardiac output after 72 hours CRT (versus control) treatment

Secondary Outcome Measures :
  1. Echocardiographic measures of left ventricular (LV) function
  2. Mixed venous oxygen saturation
  3. Invasively determined cardiac output
  4. Plasma brain natriuretic peptide (p-BNP)
  5. Number of hours with inotropic treatment


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192946


Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Jesper H Svendsen, MD Rigshospitalet, Denmark

ClinicalTrials.gov Identifier: NCT00192946     History of Changes
Other Study ID Numbers: KF 01-230/04
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: July 10, 2007
Last Verified: February 2006

Keywords provided by Rigshospitalet, Denmark:
Cardiac resynchronization
Heart failure
open heart surgery
surgery

Additional relevant MeSH terms:
Bundle-Branch Block
Heart Block
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes