Morbidity, Mortality and Gender Differences in Patients With Pacemakers

Completed

• Conditions: Cardiac Pacing, Artificial; Pacemaker, Artificial; Cohort Studies; Arrhythmias Requiring Therapy
• Interventions: Other: No intervention, retrospective analysis only.

• Registration Number: NCT03388281
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-28
• Primary Completion: 2016-03-31
• Study Completion: 2016-03-31
• Status Verified: 2017-12
• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2017-12-29
• Last Update Submitted: 2017-12-29
• Study First Posted: 2018-01-02
• Last Update Posted: 2018-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11444

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with implanted pacemaker	No intervention, retrospective analysis only.	Patients with implanted cardiac pacemaker registered in pacemaker database of the Department of Cardiology at the Medical University Vienna were included.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Implantation rates of single- or dual-chamber Pacemaker in women/men.	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.	10 years	Null hypothesis: Survival after single- or dual-chamber pacemaker implantation is equal.