NCT00192946

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

July 10, 2007

Status Verified

February 1, 2006

First QC Date

September 11, 2005

Last Update Submit

July 9, 2007

Conditions

Bundle-Branch Block

Keywords

Cardiac resynchronizationHeart failureopen heart surgerysurgery

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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

Interventions

Temporary cardiac resynchronization therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Severe right heart failure
  • Permanent atrial fibrillation
  • Congenital heart disease
  • Serious non-cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bundle-Branch BlockHeart Failure

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jesper H Svendsen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Completion

September 1, 2008

Last Updated

July 10, 2007

Record last verified: 2006-02