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Quality of Life (QOL) and Impact of StressNCT07343466

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

An observational study of Quality of Life (QOL) and Impact of Stress, run by University Hospital, Essen at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Survey using a questionnaire.
How many people
300 participants
Where
1 siteGermany
Study dates
4 Feb 2025to 15 Jul 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

Germany1 site, 1 recruiting

  • Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie

    Essen, North Rhine-Westphalia, 45147

    Julia Lortz, Prof. Dr. med., +49 201-723 84995, julia.lortz@uk-essen.de

    Muhammed Kurt, Dr. med., +49 201-723 86255, muhammed.kurt@uk-essen.de

    Recruiting

Other trials in Germany

About this study

Official title: Klinische Studie Zur Untersuchung Der Lebensqualität Und Des Einflusses Von Stress Auf Den Postoperativen Verlauf Von Patienten Nach Device-Implantation

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.

Being tested
Survey using a questionnaire.
Keywords
Impact of Stress, postoperative course, ICD, CRT, Pacemaker, Event-Recorder, prospektive, Quality of life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT07343466
Study groupRoleWhat they receive
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.
Receives: Other: Survey using a questionnaire.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 36 Months

Secondary outcomes (16)

  1. hospitalisation rate

    Analyzes how often and when the Patient got hospitalized

    Measured: 36 Months

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

    Following device implantation, subsequent follow-up evaluations include device interrogation to assess stored arrhythmic events. Specifically, the analysis focuses on the detection of ventricular tachycardia and ventricular fibrillation. The frequency of these arrhythmias is systematically recorded for each study participant.

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

  3. Changes in functional capacity

    changes in functional capacity will be recorded using the established 6-minute walk test. The unit of measurement for the distance covered in 6 minutes will be meters.

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

  4. combined global stress measure

    The outcome is based on a published RCT in Circulation by Blumenthal et al. . A global stress measure (mean rank), was the primary outcome combining the following components at baseline and following treatment: Beck Depression Inventory II, Spielberger Anxiety Inventory-State, General Health Questionnaire, PROMIS Anger Questionnaire, and Perceived Stress Scale. A range from 1 to 147 was present with higher scores suggestive of better function. The change in each individual scaled score is presented in secondary outcome. (see also NCT00981253)

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

  5. Health-related quality of life - SF-36

    The investigators will apply the Short Form-36 health questionnaire [36,37]. The SF-36 is an eight-dimensional scale consisting of 36 items. It assesses health-related quality of life based on physical, social, and psychological functioning, role behavior due to physical and psychological functional impairment, physical pain, general health perception, and vitality.

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

  6. Health-related Quality of life - EQ-5D-5L

    The investigators will apply the European Quality of Life 5 Dimensions 5 Level survey (EQ-5D-5L) [36,37]. The EQ-5D-5L consists of five health-related dimensions that can be assessed at five levels.

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

  7. Health-related Quality of life - VAS for general health

    The questionnaire contains a visual analog scale for assessing general health. It consists of a straight line from 0 to 100, with endpoints representing extreme values-such as "worst imaginable health" on one side and "best imaginable health" on the other. The participants mark a position on the line. The position of the mark provides a numerical value.

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

  8. Depression symptoms (BDI-II)

    The BDI-II is a self-report questionnaire comprising 21 items that assess depression severity. Its reliability and validity have been established through various studies among diverse populations and cultural backgrounds. Higher scores indicates increased depression symptoms

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

  9. Anxiety symptoms (STAI)

    The STAI is the most authoritative tool for assessing anxiety in adults, precisely distinguishing between transient "state anxiety" and persistent "trait anxiety". The STAI measures anxiety with 20 items and has a range of 20 to 80. A higher score indicates more pronounced anxiety

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

  10. PROMIS-Anger Scale

    The PROMIS Anger scale comprises eight items that evaluate various aspects of anger. Scores on the scale range from 8 to 40, with higher scores indicating greater levels of anger

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

  11. GHQ, Evaluation of distress

    The GHQ assesses general distress and consists of 12 items. Respondents' scores range from 0 to 36, where higher scores correspond to increased distress

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

  12. Perceived Stress Scale

    The Perceived Stress Scale-10 item version is a short tool for the assessment of how individuals perceive stress in their lives. The values range from 0 to 40. Higher values indicate higher perceived stress.

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

  13. Appropriate vs. inappropriate Shocks

    All ICD shock events occurring during the follow-up period will be classified as either appropriate or inappropriate, based on predefined criteria.

    Appropriate shocks will be defined as those delivered in response to documented, life-threatening ventricular arrhythmias, including:

    • Ventricular tachycardia (VT)
    • Ventricular fibrillation (VF),

    Inappropriate shocks will be defined as those delivered in the absence of a qualifying ventricular arrhythmia. For example:

    -Supraventricular tachycardias (e.g., atrial fibrillation or flutter) misclassified as VT/VF or Oversensing due to lead malfunction, signal noise, or double counting.

    All shock events will be reviewed using intracardiac electrograms and device event logs retrieved from the ICD or CRT-D memory. When available, surface ECG data will be used to support rhythm interpretation.

    A shock will only be classified as appropriate if there is clear evidence of a ventricular arrythmia

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

  14. proinflammatory mediators- IL6

    IL-6 is measured in pg/ml. Standard value is under 4.4 pg/ml. Higher values indicate an increased stress level

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

  15. Proinflammatory mediators - CRP

    C-reactive protein (CRP) is measured in mg/dl. Standard value is under 0.5 mg/dl. Higher values indicate an increased stress level.

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

  16. Proinflammatory mediators- PCT

    Procalcitonin is measured in ng/ml. Standard value is under 0.5 ng/ml. Higher values correlate with systemic inflammatory reaction and indicate bacterial infections.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start4 Feb 2025
  3. Primary completion15 Jun 2029 (estimated)
  4. Study completion15 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07343466
Sponsor's protocol ID
24-12310-BO
Status last verified
Jun 2025
First submitted
15 Aug 2025
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All collected data will be stored in pseudonymized form and retained for 10 years after completion or termination of the study, after which it will be destroyed. All study documents, including the pseudonymized list, will be stored and managed on the clinic's own servers. Access to data storage and management will be restricted to authorized personnel (study management, relevant study physicians, and medical doctoral students). Data will not be shared with third parties.

Publications

  • 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.

    PubMed 25888514

  • 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.

    PubMed 36638700

  • 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.

    PubMed 31979074

  • 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.

    PubMed 33787324

  • 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.

    PubMed 30929706

  • 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.

    PubMed 24081953

  • 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.

    PubMed 10879374

  • 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.

    PubMed 31617405

  • 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.

    PubMed 36361008

  • 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.

    PubMed 27748467

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life (QOL) and Impact of Stress, run by University Hospital, Essen at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Muhammed Kurt, Dr. med. (+49 201-723 86255, muhammed.kurt@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of device-related complications (time frame: 36 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07343466, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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