Morbidity, Mortality and Gender Differences in Patients With Pacemakers

NCT03388281 | Completed

• 1 other identifier: EK1525/2015
• Study Type: observational
• Target: 11,444
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Pacemaker; Gender differences; Survival; Retrospective

Outcome Measures

Primary Outcomes (1)

• Survival after pacemaker implantation

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

  10 years

Secondary Outcomes (2)

• 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

Other Outcomes (6)

• First implantation age in single- or dual-chamber pacemaker

  Data obtained: April 30th, 2015

• Time to device- or lead-replacement

  10 years

• Prevalence of Comorbidities

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

Study Arms (1)

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

No intervention, retrospective analysis only. OTHER

No intervention, retrospective analysis only.

Patients with implanted pacemaker

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Related Publications (1)

• 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.

  PMID: 33195457 DERIVED

Study Officials

• Mariann Gyöngyösi, MD, PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, Assoc. Prof. Univ.-Doz. Dr.

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 2, 2018
• Study Start: July 28, 2015
• Primary Completion: March 31, 2016
• Study Completion: March 31, 2016
• Last Updated: January 2, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share