Left Ventricular Function and Remodelling During Permanent Pacing
Primary Purpose
Sick Sinus Syndrome, AV-Block
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
AAI vs. DDD vs. BIV pacing in different patients groups
Sponsored by
About this trial
This is an interventional treatment trial for Sick Sinus Syndrome focused on measuring Sick sinus syndrome, AV-block
Eligibility Criteria
Inclusion Criteria: Sick sinus syndrome AV-block Exclusion Criteria: Atrial fibrillation AMI Heart valve disease
Sites / Locations
- Andi Eie Albertsen
Outcomes
Primary Outcome Measures
3-dimensional left ventricular ejection fraction
Secondary Outcome Measures
TDI echo parameters
6 MHW
NT-proBNP
Full Information
NCT ID
NCT00228241
First Posted
September 26, 2005
Last Updated
October 25, 2006
Sponsor
Aarhus University Hospital Skejby
1. Study Identification
Unique Protocol Identification Number
NCT00228241
Brief Title
Left Ventricular Function and Remodelling During Permanent Pacing
Official Title
Left Ventricular Function and Remodelling During Permanent Pacing
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Aarhus University Hospital Skejby
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sick Sinus Syndrome, AV-Block
Keywords
Sick sinus syndrome, AV-block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
AAI vs. DDD vs. BIV pacing in different patients groups
Primary Outcome Measure Information:
Title
3-dimensional left ventricular ejection fraction
Secondary Outcome Measure Information:
Title
TDI echo parameters
Title
6 MHW
Title
NT-proBNP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sick sinus syndrome
AV-block
Exclusion Criteria:
Atrial fibrillation
AMI
Heart valve disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andi Albertsen, MD
Organizational Affiliation
Physician, Skejby University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Andi Eie Albertsen
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
21857020
Citation
Albertsen AE, Mortensen PT, Jensen HK, Poulsen SH, Egeblad H, Nielsen JC. Adverse effect of right ventricular pacing prevented by biventricular pacing during long-term follow-up: a randomized comparison. Eur J Echocardiogr. 2011 Oct;12(10):767-72. doi: 10.1093/ejechocard/jer136. Epub 2011 Aug 20.
Results Reference
derived
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Left Ventricular Function and Remodelling During Permanent Pacing
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