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

Medical University of Vienna0 sites11,444 target enrollmentJuly 28, 2015

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pacemaker, Artificial
Sponsor: Medical University of Vienna
Enrollment: 11444
Primary Endpoint: Survival after pacemaker implantation
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 28, 2015

End Date

March 31, 2016

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medical University of Vienna

Responsible Party

Principal Investigator

Mariann Gyongyosi

Cardiologist, Assoc. Prof. Univ.-Doz. Dr.

Medical University of Vienna

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.

Outcomes

Primary Outcomes

Survival after pacemaker implantation

Time Frame: 10 years

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

Secondary Outcomes

Implantation rates of single- or dual-chamber Pacemaker in women/men.(Data obtained: April 30th, 2015)
Survival of women/men after single- or dual-chamber pacemaker implantation.(10 years)