The CRT-KIR Study (Cardiac Resynchronization Therapy [CRT... | NCT00192946

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

NCT00192946

Sponsor

Rigshospitalet, Denmark

Status

Withdrawn

Last Update Posted

Jul 10, 2007Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Bundle-Branch Block

Interventions

Temporary cardiac resynchronization therapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2006

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study population is smaller than expected. No subjects were included.

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Sep 2008Estimated

First Submitted Date

Sep 11, 2005

First Submission Date that Met QC Criteria

Sep 16, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2007

Last Update Posted Date

Jul 10, 2007Estimated

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Name	Type	Description	Arm Group Labels	Other Names
Temporary cardiac resynchronization therapy	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Non invasive cardiac output after 72 hours CRT (versus control) treatment

Secondary Outcomes

Measure	Description	Time Frame
Echocardiographic measures of left ventricular (LV) function
Mixed venous oxygen saturation
Invasively determined cardiac output

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jesper H Svendsen, MD	Rigshospitalet, Denmark	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D002037	Bundle-Branch Block
D006333	Heart Failure

Ancestor Terms

ID	Term
D006327	Heart Block
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided