Bundle-Branch BlockNCT00192946
The CRT-KIR Study (Cardiac Resynchronization Therapy [CRT] in the Early Phase After Heart Surgery)
A study testing Temporary cardiac resynchronization therapy in people with Bundle-Branch Block, run by Copenhagen University Hospital, Rigshospitalet.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bundle-Branch Block
- What is being tested?
- Temporary cardiac resynchronization therapy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Severe right heart failure
- Permanent atrial fibrillation
- Congenital heart disease
- Serious non-cardiac disease
About this study
Official title: 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.
Read the 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.
- Conditions
- Bundle-Branch Block
- Being tested
- Temporary cardiac resynchronization therapy
- Keywords
- Cardiac resynchronization, Heart failure, open heart surgery, surgery
- Medical subject headings
- Bundle-Branch Block, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary cardiac resynchronization therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study completionSep 2008 (estimated)
Why it stopped: The study population is smaller than expected. No subjects were included.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bundle-Branch BlockStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Jesper H Svendsen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192946
- Sponsor's protocol ID
- KF 01-230/04
- Status last verified
- Feb 2006
- First submitted
- 11 Sep 2005
- Last updated
- 10 Jul 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Resynchronization Therapy (CRT) in the Early Phase After Heart Surgery
- ClinicalTrials.gov ID
- NCT00192946
- Acronym / sponsor ID
- KF 01-230/04
- Conditions
- Bundle-Branch Block
- Keywords
- Cardiac resynchronization, Heart failure, open heart surgery, surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study population is smaller than expected. No subjects were included.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study completion
- Sep 2008 (estimated)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- Severe right heart failure
- Permanent atrial fibrillation
- Congenital heart disease
- Serious non-cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary cardiac resynchronization therapy | Procedure or surgery | – |
Primary outcome
Non invasive cardiac output after 72 hours CRT (versus control) treatment
5 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2007.
Related trials for Bundle-Branch Block
Active, not recruiting
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Left Ventricular Ejection Fraction, Heart Failure (HF)
Recruiting
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
Aortic Valve Disease, Conduction Disturbances
Not yet recruiting
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
Recruiting
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
Heart Failure, Systolic Bundle Branch Block, Left
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper H Svendsen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
A study testing Temporary cardiac resynchronization therapy in people with Bundle-Branch Block, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non invasive cardiac output after 72 hours CRT (versus control) treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2007.