Morbidity, Mortality and Gender Differences in Patients With Pacemakers

Overview

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.

Full Title of Study: “Morbidity, Mortality and Gender Differences in Patients With Pacemakers; a Large-scale Single-center Cohort Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: March 31, 2016

Interventions

  • Other: No intervention, retrospective analysis only.
    • No intervention, retrospective analysis only.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Survival after pacemaker implantation
    • Time Frame: 10 years
    • Null hypothesis: There is no survival difference between women and men after pacemaker Implantation.

Secondary Measures

  • Implantation rates of single- or dual-chamber Pacemaker in women/men.
    • Time Frame: Data obtained: April 30th, 2015
    • Null 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.
    • Time Frame: 10 years
    • Null hypothesis: Survival after single- or dual-chamber pacemaker implantation is equal.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Vienna
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mariann Gyongyosi, Cardiologist, Assoc. Prof. Univ.-Doz. Dr. – Medical University of Vienna
  • Overall Official(s)
    • Mariann Gyöngyösi, MD, PhD, Principal Investigator, Medical University of Vienna

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