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CompletedNCT03388281Updated Jan 2, 2018

Morbidity, Mortality and Gender Differences in Patients With Pacemakers

An observational study in Pacemaker, Artificial, Cohort Studies and Arrhythmias Requiring Therapy, sponsored by Medical University of Vienna. Completed. Per ClinicalTrials.gov, last updated 2018-01-02.

Sponsored by Medical University of Vienna · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
11,444
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • Pacemaker
  • Gender differences
  • Survival
  • Retrospective
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
11,444 participants (actual)
Patient registry
No

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.

    Other: No intervention, retrospective analysis only.

Interventions

  • OtherNo intervention, retrospective analysis only.

    No intervention, retrospective analysis only.

05

What researchers measure

Primary outcomes

  1. Survival after pacemaker implantation

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

    Time frame: 10 years

Secondary outcomes

  1. 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.

    Time frame: Data obtained: April 30th, 2015

  2. Survival of women/men after single- or dual-chamber pacemaker implantation.

    Null hypothesis: Survival after single- or dual-chamber pacemaker implantation is equal.

    Time frame: 10 years

Other outcomes

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

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

    Time frame: Data obtained: April 30th, 2015

  2. Time to device- or lead-replacement

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

    Time frame: 10 years

  3. Prevalence of Comorbidities

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

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

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

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

    Time frame: 10 years

  5. Pacemaker parameters

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

    Time frame: Data obtained: April 30th, 2015

  6. Laboratory results

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

    Time frame: Data obtained: March 2nd, 2016

06

Study locations

No study locations are listed for this record.

07

References and documents

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 ↗

Individual participant data

Plan to share: Yes — Sharing of IPD is planned.

08

Registry details

Key details

Study ID
NCT03388281
Lead sponsor
Medical University of Vienna
Responsible party
Mariann Gyongyosi (Cardiologist, Assoc. Prof. Univ.-Doz. Dr., Medical University of Vienna) — Principal investigator
First posted
Jan 2, 2018
Start date
Jul 28, 2015
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016
Last update
Jan 2, 2018

Study contacts

Mariann Gyöngyösi, MD, PhD
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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