Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation

NCT07343466 | Recruiting

• 1 other identifier: 24-12310-BO
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The project "Investigating Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation" aims to investigate the relationship between stress and the postoperative healing process of patients who have had a medical device implanted. These devices include pacemakers for the treatment of bradycardia, implantable cardioverter-defibrillators (ICDs) for the treatment of tachycardia in primary and secondary prevention, and cardiac resynchronization therapy (CRT) devices and event recorders. The study will analyze the influence of stress on the postoperative course, potential complications, and overall quality of life. A combination of medical examinations and surveys will be used to analyze how psychological stress influences the physical healing process and which measures can contribute to improving quality of life and treatment success. The surgical procedure for implanting devices is not part of the study; this is an observational study.

Conditions

Quality of Life (QOL) and Impact of Stress

Keywords

Impact of Stress; postoperative course; ICD; CRT; Pacemaker; Event-Recorder; prospektive; Quality of life

Outcome Measures

Primary Outcomes (1)

• Cumulative incidence of device-related complications

  Measures the incidence of device-related complications, this includes: Complications related to Device- pockets, leads and infections connected to the devices

  36 Months

Secondary Outcomes (16)

• hospitalisation rate

  36 Months

• Number of participants with the following arrhythmic events: ventrikular tachykardia and ventrikular fibrillation

  Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months

• Changes in functional capacity

  Baseline (at 4-6 weeks) , after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months

• combined global stress measure

  Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months

• Health-related quality of life - SF-36

  Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months

Study Arms (1)

Patients with indication for device implantation (pacemaker, ICD, CRT, event recorder)

Patients with cardiac diseases, that makes a device implantation (pacemaker, ICD, CRT, event recorder) necessary, including primary and secondary indication for an ICD.

Other: Survey using a questionnaire.

Interventions

Survey using a questionnaire. OTHER

survery over 36 months with comparison of the questionnares with risk-factors, blood-samples and physical fitness of the patient

Patients with indication for device implantation (pacemaker, ICD, CRT, event recorder)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication for device implantation (pacemaker, ICD, CRT, event recorder) who present at the Department of Cardiology and Angiology at the University Hospital Essen

You may qualify if:

• Patients of legal capacity with an indication for device implantation (pacemaker, ICD, CRT, event recorder) who present at the Department of Cardiology and Angiology at the University Hospital Essen and consent to participate in the study will be included.

You may not qualify if:

• none

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

Related Publications (10)

• Golbidi S, Frisbee JC, Laher I. Chronic stress impacts the cardiovascular system: animal models and clinical outcomes. Am J Physiol Heart Circ Physiol. 2015 Jun 15;308(12):H1476-98. doi: 10.1152/ajpheart.00859.2014. Epub 2015 Apr 17.

  PMID: 25888514 BACKGROUND

• Pedersen SS, Wehberg S, Nielsen JC, Riahi S, Larroude C, Philbert BT, Johansen JB; DEFIB-WOMEN Investigators. Patients with an implantable cardioverter defibrillator at risk of poorer psychological health during 24 months of follow-up (results from the Danish national DEFIB-WOMEN study). Gen Hosp Psychiatry. 2023 Jan-Feb;80:54-61. doi: 10.1016/j.genhosppsych.2022.12.006. Epub 2023 Jan 3.

  PMID: 36638700 BACKGROUND

• Kim J, Park JK, Choi J, Kim SH, On YK, Shin MS, Choi N, Heo S. Changes in the Physical Function and Psychological Distress from Pre-Implant to 1, 6, and 12 Months Post-Implant in Patients Undergoing Implantable Cardioverter Defibrillator Therapy. J Clin Med. 2020 Jan 22;9(2):307. doi: 10.3390/jcm9020307.

  PMID: 31979074 BACKGROUND

• van Barreveld M, Verstraelen TE, van Dessel PFHM, Boersma LVA, Delnoy PPHM, Tuinenburg AE, Theuns DAMJ, van der Voort PH, Kimman GJ, Buskens E, Zwinderman AH, Wilde AAM, Dijkgraaf MGW; DO-IT Registry Investigators. Dutch Outcome in Implantable Cardioverter-Defibrillator Therapy: Implantable Cardioverter-Defibrillator-Related Complications in a Contemporary Primary Prevention Cohort. J Am Heart Assoc. 2021 Apr 6;10(7):e018063. doi: 10.1161/JAHA.120.018063. Epub 2021 Mar 31.

  PMID: 33787324 BACKGROUND

• Miller JL, Thylen I, Elayi SC, Etaee F, Fleming S, Czarapata MM, Lennie TA, Moser DK. Multi-morbidity burden, psychological distress, and quality of life in implantable cardioverter defibrillator recipients: Results from a nationwide study. J Psychosom Res. 2019 May;120:39-45. doi: 10.1016/j.jpsychores.2019.03.006. Epub 2019 Mar 5.

  PMID: 30929706 BACKGROUND

• Lampert R. Managing with pacemakers and implantable cardioverter defibrillators. Circulation. 2013 Oct 1;128(14):1576-85. doi: 10.1161/CIRCULATIONAHA.113.001555. No abstract available.

  PMID: 24081953 BACKGROUND

• Linde C. Quality-of-life in pacemaker and implantable cardioverter defibrillator recipients. Pacing Clin Electrophysiol. 2000 Jun;23(6):931-3. doi: 10.1111/j.1540-8159.2000.tb00876.x. No abstract available.

  PMID: 10879374 BACKGROUND

• Su SF, Wu MS. Arrhythmia Perception and Quality of Life in Bradyarrhythmia Patients Following Permanent Pacemaker Implantation. Clin Nurs Res. 2021 Feb;30(2):183-192. doi: 10.1177/1054773819880297. Epub 2019 Oct 16.

  PMID: 31617405 BACKGROUND

• Sikora K, Wawryniuk A, Luczyk RJ, Sawicka K, Zwolak A. The Occurrence of Stress, Illness Acceptance and the Quality of Life of Patients after Pacemaker Implantation. Int J Environ Res Public Health. 2022 Oct 29;19(21):14133. doi: 10.3390/ijerph192114133.

  PMID: 36361008 BACKGROUND

• Iliou MC, Blanchard JC, Lamar-Tanguy A, Cristofini P, Ledru F. Cardiac rehabilitation in patients with pacemakers and implantable cardioverter defibrillators. Monaldi Arch Chest Dis. 2016 Oct 14;86(1-2):756. doi: 10.4081/monaldi.2016.756.

  PMID: 27748467 BACKGROUND

Study Officials

• Tienush Rassaf, Univ.-Prof. Dr. med.

  Universitätsklinikum Essen

  STUDY CHAIR

• Julia Lortz, Prof. Dr. med.

  Universitätsklinikum Essen

  STUDY DIRECTOR

• Muhammed Kurt, Dr. med.

  Universitätsklinikum Essen

  STUDY DIRECTOR

Central Study Contacts

Muhammed Kurt, Dr. med.

CONTACT

+49 201-723 86255; muhammed.kurt@uk-essen.de

Julia Lortz, Prof. Dr. med.

CONTACT

+49 201-723 84995; julia.lortz@uk-essen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: January 15, 2026
• Study Start: February 4, 2025
• Primary Completion (Estimated): June 15, 2029
• Study Completion (Estimated): July 15, 2029
• Last Updated: January 15, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)