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Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Longitudinal Observational Study

NCT06654284 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2025-12-01

No results posted yet for this study

Summary

Patients at risk for life-threatening arrhythmias are eligible for the implantation of an implantable cardioverter-defibrillator (ICD), which has repeatedly shown improved survival. However, living with an ICD may pose several challenges and affect quality of life (QoL). This prospective longitudinal observational cohort studies will provide detailed insights in the change of patient-reported QoL after ICD impalntation. The aim is to study the change in time of the QoL perspective of patients who have an ICD, including physical and emotional health; ICD acceptance; concerns of ICD patients with regard to physical and sexual activity.

Conditions

  • Implantable Cardioverter Defibrillator (ICD)

Interventions

OTHER

quality of life questionnaires

All patients will receive a combination of quality of life questionnaires aimed at predeifined time points (baseline, 3 months, 1 year, 3 year, 6 year, 9 year and 12 year) collecting a complete overview of different aspects of quality of life, including: - Florida patient acceptance score (FPAS) - Short Form Health Survey (SF-12) - Kansas City Cardiomyopathy Questionnaire (KCCQ-12) - Hospital Anxiety and Depression Scale (HADS) - Florida Shock Acceptance score (FSAS) - Steinke Sexual Concerns Inventory - the "Good Death" questionnaire

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-18
Primary Completion
2042-12-31
Completion
2042-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06654284 on ClinicalTrials.gov