NCT06654284

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-09-18
• Primary completion: 2042-12-01
• Completion: 2042-12-01
• First posted: 2024-10-23
• Last updated: 2025-12-01

Locations

1 site across 1 country: Belgium