Pacemaker, ArtificialNCT03388281
Morbidity, Mortality and Gender Differences in Patients With Pacemakers
An observational study of Pacemaker, Artificial and Cohort Studies, run by Medical University of Vienna.
Trial summary
Previous publications suggest gender difference in outcome parameters after pacemaker implantation. Aim of this study is to investigate gender differences in patients with pacemaker. Implanted devices, indication for implantation and pacemaker follow up data of patients will be included. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pacemaker, Artificial, Cohort Studies, Arrhythmias Requiring Therapy
- How many people
- 11,444 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2015to 31 Mar 2016
- 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: Women and men with implanted cardiac Pacemaker and at least one follow up in our Pacemaker Office of the Department of Cardiology at the Medical University Vienna. Patients were enrolled regardless of time and place of pacemaker implantations.
Who may be able to join
- All patients registered in the pacemaker database of the Department of Cardiology at the Medical University Vienna. Patients get registered when clinical follow up of an implanted Pacemaker is done.
Who cannot join
- For survival analysis: No valid match of first name AND surname AND date of birth with patients' insurance data.
- For analysis of comorbidities: Not a single documented diagnose was found in our electronic clinic-wide patients' information system.
About this study
Official title: Morbidity, Mortality and Gender Differences in Patients With Pacemakers; a Large-scale Single-center Cohort Study
Previous publications suggest gender difference in outcome parameters after pacemaker implantation. Aim of this study is to investigate gender differences in patients with pacemaker. Implanted devices, indication for implantation and pacemaker follow up data of patients will be included. Survival data including cause of death will be documented. Prevalent comorbidities and relevant laboratory data will be recorded.
- Conditions
- Pacemaker, Artificial, Cohort Studies, Arrhythmias Requiring Therapy, Cardiac Pacing, Artificial
- Being tested
- No intervention, retrospective analysis only.
- Keywords
- Pacemaker, Gender differences, Survival, Retrospective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, retrospective analysis only.Other
No intervention, retrospective analysis only.
| Study group | Role | What they receive |
|---|---|---|
| Patients with implanted pacemaker | Patients with implanted cardiac pacemaker registered in pacemaker database of the Department of Cardiology at the Medical University Vienna were included. Receives: Other: No intervention, retrospective analysis only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival after pacemaker implantation
Null hypothesis: There is no survival difference between women and men after pacemaker Implantation.
Measured: 10 years
Secondary outcomes (2)
Implantation rates of single- or dual-chamber Pacemaker in women/men.
Null hypothesis: Women and men have equal implantation rates of single- and dual-chamber pacemakers.
Measured: Data obtained: April 30th, 2015
Survival of women/men after single- or dual-chamber pacemaker implantation.
Null hypothesis: Survival after single- or dual-chamber pacemaker implantation is equal.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start28 Jul 2015
- Primary completion31 Mar 2016
- Study completion31 Mar 2016
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 Pacemaker, ArtificialStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariann Gyongyosi, Medical University of Vienna
- Investigators
- Mariann Gyöngyösi, MD, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388281
- Sponsor's protocol ID
- EK1525/2015
- Status last verified
- Dec 2017
- First submitted
- 22 Dec 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of IPD is planned.
Publications
Riesenhuber M, Spannbauer A, Rauscha F, Schmidinger H, Boszotta A, Pezawas T, Schukro C, Gwechenberger M, Stix G, Anvari A, Wrba T, Khazen C, Andreas M, Laufer G, Hengstenberg C, Gyongyosi M. Sex Differences and Long-Term Outcome in Patients With Pacemakers. Front Cardiovasc Med. 2020 Sep 22;7:569060. doi: 10.3389/fcvm.2020.569060. eCollection 2020.
PubMed 33195457
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity, Mortality and Gender Differences in Patients With Pacemakers; a Large-scale Single-center Cohort Study
- ClinicalTrials.gov ID
- NCT03388281
- Acronym / sponsor ID
- EK1525/2015
- Conditions
- Pacemaker, Artificial, Cohort Studies, Arrhythmias Requiring Therapy, Cardiac Pacing, Artificial
- Keywords
- Pacemaker, Gender differences, Survival, Retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,444 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 28 Jul 2015 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 2 Jan 2018 (actual)
- 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.
Previous publications suggest gender difference in outcome parameters after pacemaker implantation. Aim of this study is to investigate gender differences in patients with pacemaker. Implanted devices, indication for implantation and pacemaker follow up data of patients will be included. Survival data including cause of death will be documented. Prevalent comorbidities and relevant laboratory data will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with implanted pacemaker | – | Other: No intervention, retrospective analysis only.Patients with implanted cardiac pacemaker registered in pacemaker database of the Department of Cardiology at the Medical University Vienna were included. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women and men with implanted cardiac Pacemaker and at least one follow up in our Pacemaker Office of the Department of Cardiology at the Medical University Vienna. Patients were enrolled regardless of time and place of pacemaker implantations.
Key inclusion criteria (1 listed)
- All patients registered in the pacemaker database of the Department of Cardiology at the Medical University Vienna. Patients get registered when clinical follow up of an implanted Pacemaker is done.
Key exclusion criteria (2 listed)
- For survival analysis: No valid match of first name AND surname AND date of birth with patients' insurance data.
- For analysis of comorbidities: Not a single documented diagnose was found in our electronic clinic-wide patients' information system.
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 |
|---|---|---|
| No intervention, retrospective analysis only.No intervention, retrospective analysis only. | Other | Patients with implanted pacemaker |
Primary outcome
Survival after pacemaker implantation
Time frame: 10 years
Null hypothesis: There is no survival difference between women and men after pacemaker Implantation.
2 secondary outcomes
Implantation rates of single- or dual-chamber Pacemaker in women/men.
Time frame: Data obtained: April 30th, 2015
Survival of women/men after single- or dual-chamber pacemaker implantation.
Time frame: 10 years
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 2 Jan 2018.
- Derived from this study: PubMed 33195457Riesenhuber M, Spannbauer A, Rauscha F, Schmidinger H, Boszotta A, Pezawas T, Schukro C, Gwechenberger M, Stix G, Anvari A, Wrba T, Khazen C, Andreas M, Laufer G, Hengstenberg C, Gyongyosi M. Sex Differences and Long-Term Outcome in Patients With Pacemakers. Front Cardiovasc Med. 2020 Sep 22;7:569060. doi: 10.3389/fcvm.2020.569060. eCollection 2020.
- Individual participant dataSharing planned: Yes. Sharing of IPD is planned.
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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.
Mariann Gyöngyösi, MD, PhD principal investigator
Medical University of Vienna
Questions about this trial
What is this clinical trial studying?
An observational study of Pacemaker, Artificial and Cohort Studies, run by Medical University of Vienna.
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 2 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 2 Jan 2018. 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 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.
What does the primary outcome measure?
Survival after pacemaker implantation (time frame: 10 years). 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 NCT03388281, 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 2 Jan 2018.