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Enrolling by invitation NCT06654284

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

— Observational Implantable Cardioverter Defibrillator (ICD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: quality of life questionnaires.
Who it may be relevant to
Registry conditions: Implantable Cardioverter Defibrillator (ICD). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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 In

Primary outcome measures

  • General QoL assessed using the Short Form Health Survey (SF-12) [Time frame: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years]
Secondary outcome measures (5)
  • - Cardiac-specific QoL assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) [Time frame: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years]
  • Florida Shock Acceptance score (FSAS) [Time frame: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years]
  • ICD acceptance assessed using the Florida Patient Acceptance Survey (FPAS) [Time frame: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years]
  • Steinke Sexual Concerns Inventory [Time frame: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years]
  • "Concept of a Good Death" questionnaire [Time frame: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • UZ Leuven — Leuven

Identifiers

NCT: NCT06654284 · S69418

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗