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Morbidity, Mortality and Gender Differences in Patients With Pacemakers

Morbidity, Mortality and Gender Differences in Patients With Pacemakers; a Large-scale Single-center Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03388281
Enrollment
11444
Registered
2018-01-02
Start date
2015-07-28
Completion date
2016-03-31
Last updated
2018-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias Requiring Therapy, Cardiac Pacing, Artificial, Cohort Studies, Pacemaker, Artificial

Keywords

Pacemaker, Gender differences, Survival, Retrospective

Brief 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. Survival data including cause of death will be documented. Prevalent comorbidities and relevant laboratory data will be recorded.

Interventions

OTHERNo intervention, retrospective analysis only.

No intervention, retrospective analysis only.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Survival after pacemaker implantation10 yearsNull hypothesis: There is no survival difference between women and men after pacemaker Implantation.

Secondary

MeasureTime frameDescription
Implantation rates of single- or dual-chamber Pacemaker in women/men.Data obtained: April 30th, 2015Null hypothesis: Women and men have equal implantation rates of single- and dual-chamber pacemakers.
Survival of women/men after single- or dual-chamber pacemaker implantation.10 yearsNull hypothesis: Survival after single- or dual-chamber pacemaker implantation is equal.

Other

MeasureTime frameDescription
Survival and device/lead-replacement in patients with diabetes.10 yearsNull hypothesis: There is no difference in survival or device/lead-replacement rates in women/men with diabetes.
First implantation age in single- or dual-chamber pacemakerData obtained: April 30th, 2015Null hypothesis: There is no difference in first implantation age between sexes and single- or dual-chamber pacemakers.
Laboratory resultsData obtained: March 2nd, 2016Null hypothesis: There is no difference between women and men in troponin T, N-terminal pro-brain natriuretic Peptide, HbA1c and low-density lipoprotein.
Pacemaker parametersData obtained: April 30th, 2015Null hypothesis: There is no difference between women and men in pacing threshold and lead impedance.
Time to device- or lead-replacement10 yearsNull hypothesis: There is no difference between women and men in time to device- or lead-replacement.
Prevalence of ComorbiditiesSurvival analysis: 10 years; data obtained: March 2nd, 2016Null hypothesis: There is no difference in survival and first pacemaker implantation when selected comorbidity was found.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026