Left Ventricular Function and Remodelling During Permanent Pacing
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|ClinicalTrials.gov Identifier: NCT00228241|
Recruitment Status : Unknown
Verified September 2005 by Aarhus University Hospital Skejby.
Recruitment status was: Active, not recruiting
First Posted : September 28, 2005
Last Update Posted : October 26, 2006
- Background - Pacemaker treatment gives asynchronous activation of the heart that often results in decreased heart function and clinical heart failure. New pacemaker types that stimulates both left and right ventricle ( biventricular pacemakers ) is introduced to the treatment of patients with heart failure, decreased left ventricular function and ECG signs with left bundle branch block.
- Hypothesis - Ventricular pacing results in remodelling of the left ventricle and decreased left ventricular function. Biventricular pacing do not do this. Ventricular pacing results in heart failure and increased wall stress with decreased 6 minutes walk test and increased BNP in blood samples. This is not seen by biventricular pacing.
- Materials and methods - 3 studies. All patients are examined by echocardiography 2-dimensional, M-mode, 3-dimensional and with tissue harmonic imaging. Study 1) Patients with AV-conduction disorder that needs pacemaker treatment are randomized to DDD-pacemaker or biventricular pacemaker. Study 2) Patients with sick sinus syndrome included in DANPACE are randomized to AAI- or DDD-pacemaker. Study 3 ) Acute study to examine the changes in patients AV-block before DDD-pacemaker implantation and after implantation.
|Condition or disease||Intervention/treatment|
|Sick Sinus Syndrome AV-Block||Device: AAI vs. DDD vs. BIV pacing in different patients groups|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Left Ventricular Function and Remodelling During Permanent Pacing|
|Study Start Date :||September 2003|
|Estimated Study Completion Date :||July 2006|
- 3-dimensional left ventricular ejection fraction
- TDI echo parameters
- 6 MHW
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228241
|Andi Eie Albertsen|
|Aarhus, Denmark, 8200|
|Study Chair:||Andi Albertsen, MD||Physician, Skejby University Hospital|