Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Longitudinal Observational Study (QoL-ICD II)

Universitaire Ziekenhuizen KU Leuven

Status: Invitation-only

Conditions: Implantable Cardioverter Defibrillator (ICD)

Treatments: Other: quality of life questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT06654284

S69418

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years of age
• Patients either scheduled for a new ICD implantation or scheduled for an elective generator change
• Willing and able to provide signed written informed consent.

Exclusion criteria

• Patients with a mental disability