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Completed

NCT Number: NCT03388281

Morbidity, Mortality and Gender Differences in Patients With Pacemakers

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention, retrospective analysis only.

Other

No intervention, retrospective analysis only.

Primary outcomes

  1. Survival after pacemaker implantation

    Time frame: 10 years

    Null hypothesis: There is no survival difference between women and men after pacemaker Implantation.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. First implantation age in single- or dual-chamber pacemaker

    Time frame: Data obtained: April 30th, 2015

    Null hypothesis: There is no difference in first implantation age between sexes and single- or dual-chamber pacemakers.

  2. Time to device- or lead-replacement

    Time frame: 10 years

    Null hypothesis: There is no difference between women and men in time to device- or lead-replacement.

  3. Prevalence of Comorbidities

    Time frame: Survival analysis: 10 years; data obtained: March 2nd, 2016

    Null hypothesis: There is no difference in survival and first pacemaker implantation when selected comorbidity was found.

  4. Survival and device/lead-replacement in patients with diabetes.

    Time frame: 10 years

    Null hypothesis: There is no difference in survival or device/lead-replacement rates in women/men with diabetes.

  5. Pacemaker parameters

    Time frame: Data obtained: April 30th, 2015

    Null hypothesis: There is no difference between women and men in pacing threshold and lead impedance.

  6. Laboratory results

    Time frame: Data obtained: March 2nd, 2016

    Null hypothesis: There is no difference between women and men in troponin T, N-terminal pro-brain natriuretic Peptide, HbA1c and low-density lipoprotein.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 2, 2018
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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