Morbidity, Mortality and Gender Differences in Patients With Pacemakers

Cardiac Pacing, Artificial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388281
• Other study ID #: EK1525/2015
• Status: Completed
• Phase: N/A
• First received: December 22, 2017
• Last updated: December 29, 2017
• Start date: July 28, 2015
• Est. completion date: March 31, 2016

Study information

• Verified date: December 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11444
• Est. completion date: March 31, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• No intervention, retrospective analysis only.
No intervention, retrospective analysis only.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Data obtained: April 30th, 2015
Other	Time to device- or lead-replacement	Null hypothesis: There is no difference between women and men in time to device- or lead-replacement.	10 years
Other	Prevalence of Comorbidities	Null hypothesis: There is no difference in survival and first pacemaker implantation when selected comorbidity was found.	Survival analysis: 10 years; data obtained: March 2nd, 2016
Other	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.	10 years
Other	Pacemaker parameters	Null hypothesis: There is no difference between women and men in pacing threshold and lead impedance.	Data obtained: April 30th, 2015
Other	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.	Data obtained: March 2nd, 2016
Primary	Survival after pacemaker implantation	Null hypothesis: There is no survival difference between women and men after pacemaker Implantation.	10 years
Secondary	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.	Data obtained: April 30th, 2015
Secondary	Survival of women/men after single- or dual-chamber pacemaker implantation.	Null hypothesis: Survival after single- or dual-chamber pacemaker implantation is equal.	10 years