NCT06654232

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 731 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• 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 cross-sectional observational cohort studies will provide detailed insights in patient-reported QoL. The aim is to study 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 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: 2024-11-01
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2024-10-23
• Last updated: 2025-12-01

Locations

1 site across 1 country: Belgium