Sick Sinus SyndromeNCT00228241
Left Ventricular Function and Remodelling During Permanent Pacing
A study testing AAI vs. DDD vs. BIV pacing in different patients groups in people with Sick Sinus Syndrome and AV-Block, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
1. 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sick Sinus Syndrome, AV-Block
- What is being tested?
- AAI vs. DDD vs. BIV pacing in different patients groups
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2003to Jul 2006
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sick sinus syndrome
- AV-block
Who cannot join
- Atrial fibrillation
- AMI
- Heart valve disease
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
- Conditions
- Sick Sinus Syndrome, AV-Block
- Being tested
- AAI vs. DDD vs. BIV pacing in different patients groups
- Keywords
- Sick sinus syndrome, AV-block
- Medical subject headings
- Sick Sinus Syndrome, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAI vs. DDD vs. BIV pacing in different patients groupsDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
3-dimensional left ventricular ejection fraction
Secondary outcomes (3)
TDI echo parameters
6 MHW
NT-proBNP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startSep 2003
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sick Sinus SyndromeStudies of the same condition, open and under way.
- 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
- 100 participants
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Investigators
- Andi Albertsen, MD, Study chair, Physician, Skejby University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228241
- Sponsor's protocol ID
- 130472
- Status last verified
- Sep 2005
- First submitted
- 26 Sep 2005
- Last updated
- 26 Oct 2006
- Results posted
- No
Publications
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.
PubMed 21857020
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Ventricular Function and Remodelling During Permanent Pacing
- ClinicalTrials.gov ID
- NCT00228241
- Acronym / sponsor ID
- 130472
- Conditions
- Sick Sinus Syndrome, AV-Block
- Keywords
- Sick sinus syndrome, AV-block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Jul 2006
- First posted
- 28 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sick sinus syndrome
- AV-block
Key exclusion criteria (3 listed)
- Atrial fibrillation
- AMI
- Heart valve 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 |
|---|---|---|
| AAI vs. DDD vs. BIV pacing in different patients groups | Device | – |
Primary outcome
3-dimensional left ventricular ejection fraction
3 secondary outcomes
TDI echo parameters
6 MHW
NT-proBNP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2006.
- Derived from this study: PubMed 21857020Albertsen 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.
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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.
Andi Albertsen, MD study chair
Physician, Skejby University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAI vs. DDD vs. BIV pacing in different patients groups in people with Sick Sinus Syndrome and AV-Block, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
3-dimensional left ventricular ejection fraction. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00228241, which also lists 1 linked publication.
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 26 Oct 2006.