Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation
NCT ID: NCT07343466
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2025-02-04
2029-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Survey using a questionnaire.
survery over 36 months with comparison of the questionnares with risk-factors, blood-samples and physical fitness of the patient
Interventions
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Survey using a questionnaire.
survery over 36 months with comparison of the questionnares with risk-factors, blood-samples and physical fitness of the patient
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Hospital, Essen
OTHER
Responsible Party
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Principal Investigators
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Tienush Rassaf, Univ.-Prof. Dr. med.
Role: STUDY_CHAIR
Universitätsklinikum Essen
Julia Lortz, Prof. Dr. med.
Role: STUDY_DIRECTOR
Universitätsklinikum Essen
Muhammed Kurt, Dr. med.
Role: STUDY_DIRECTOR
Universitätsklinikum Essen
Locations
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Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie
Essen, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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24-12310-BO
Identifier Type: -
Identifier Source: org_study_id
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