Clinical trial NCT03388281: Morbidity, Mortality and Gender Differences in Patients With Pacemakers
Official title: Morbidity, Mortality and Gender Differences in Patients With Pacemakers; a Large-scale Single-center Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemaker, Artificial
Cohort Studies
Arrhythmias Requiring Therapy
Cardiac Pacing, Artificial
Keywords: Pacemaker
Gender differences
Survival
Retrospective
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-01-02
Enrollment: 11444
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Survival after pacemaker implantation
timeFrame: 10 years
Secondary outcomes:
measure: Implantation rates of single- or dual-chamber Pacemaker in women/men.
timeFrame: Data obtained: April 30th, 2015
measure: Survival of women/men after single- or dual-chamber pacemaker implantation.
timeFrame: 10 years
Other outcomes:
measure: First implantation age in single- or dual-chamber pacemaker
timeFrame: Data obtained: April 30th, 2015
measure: Time to device- or lead-replacement
timeFrame: 10 years
measure: Prevalence of Comorbidities
timeFrame: Survival analysis: 10 years; data obtained: March 2nd, 2016
measure: Survival and device/lead-replacement in patients with diabetes.
timeFrame: 10 years
measure: Pacemaker parameters
timeFrame: Data obtained: April 30th, 2015
measure: Laboratory results
timeFrame: Data obtained: March 2nd, 2016
Locations:
Study officials:
affiliation: Medical University of Vienna
name: Mariann Gyöngyösi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.