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

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00192946
• Collaborator: (none)
• Enrollment: 60

Study Details

Study Description

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	Phase
Bundle-Branch Block	Procedure: Temporary cardiac resynchronization therapy	N/A

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 Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Completion Date: Sep 1, 2008

Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

• Principal Investigator: Jesper H Svendsen, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00192946
• Other Study ID Numbers: KF 01-230/04
• First Posted: Sep 19, 2005
• Last Update Posted: Jul 10, 2007
• Last Verified: Feb 1, 2006

• Keywords provided by , ,: Cardiac resynchronization; Heart failure; open heart surgery; surgery
• Additional relevant MeSH terms: Bundle-Branch Block

Study Results

No Results Posted as of Jul 10, 2007