BradycardiaNCT01038180
Complications Following Pacemaker Implantation
An observational study of Bradycardia, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study examines possible risk factors with regard to complications following pacemaker implantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bradycardia
- How many people
- 28,000 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 1997to Dec 2008
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All Danish patients receiving a permanent cardiac pacemaker during the years 1997 to 2008
Who may be able to join
- permanent cardiac pacemaker
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Aarhus University Hospital, Skejby
Aarhus, 8200
About this study
Official title: Complications Following Pacemaker or ICD Implantation: Results From The Danish Pacemaker and ICD Register
This study examines possible risk factors with regard to complications following pacemaker implantation.
Read the detailed description
This study examines possible risk factors with regard to complications following pacemaker implantation. We are using data from The Danish Pacemaker Register.
- Conditions
- Bradycardia
- Keywords
- pacemaker, adverse effects
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pacemaker group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJan 1997
- Study completionDec 2008
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 BradycardiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Rikke E Kirkfeldt, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038180
- Sponsor's protocol ID
- SKS-REK-1
- Status last verified
- Dec 2009
- First submitted
- 21 Dec 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Kirkfeldt RE, Johansen JB, Nohr EA, Moller M, Arnsbo P, Nielsen JC. Risk factors for lead complications in cardiac pacing: a population-based cohort study of 28,860 Danish patients. Heart Rhythm. 2011 Oct;8(10):1622-8. doi: 10.1016/j.hrthm.2011.04.014. Epub 2011 Apr 14.
PubMed 21699827
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications Following Pacemaker or ICD Implantation: Results From The Danish Pacemaker and ICD Register
- ClinicalTrials.gov ID
- NCT01038180
- Acronym / sponsor ID
- SKS-REK-1
- Conditions
- Bradycardia
- Keywords
- pacemaker, adverse effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28,000 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 1997
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Dec 2009 (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.
This study examines possible risk factors with regard to complications following pacemaker implantation.
Detailed description
This study examines possible risk factors with regard to complications following pacemaker implantation. We are using data from The Danish Pacemaker Register.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pacemaker group | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Danish patients receiving a permanent cardiac pacemaker during the years 1997 to 2008
Key inclusion criteria (1 listed)
- permanent cardiac pacemaker
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2009.
- Derived from this study: PubMed 21699827Kirkfeldt RE, Johansen JB, Nohr EA, Moller M, Arnsbo P, Nielsen JC. Risk factors for lead complications in cardiac pacing: a population-based cohort study of 28,860 Danish patients. Heart Rhythm. 2011 Oct;8(10):1622-8. doi: 10.1016/j.hrthm.2011.04.014. Epub 2011 Apr 14.
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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.
Rikke E Kirkfeldt, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by University of Aarhus 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 23 Dec 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01038180, 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 23 Dec 2009; AzTrials last refreshed its copy on 28 Oct 2026.