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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2008-09-30

Brief Summary

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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

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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.

Conditions

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Bundle-Branch Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Temporary cardiac resynchronization therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jesper H Svendsen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Other Identifiers

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KF 01-230/04

Identifier Type: -

Identifier Source: org_study_id