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

July 9, 2007 updated by: Rigshospitalet, Denmark

Cardiac Resynchronization Therapy (CRT) in the Early Phase After Heart Surgery

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Anticipated)

September 1, 2008

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

July 10, 2007

Last Update Submitted That Met QC Criteria

July 9, 2007

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF 01-230/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bundle-Branch Block

Clinical Trials on Temporary cardiac resynchronization therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe