Implantable Cardioverter Defibrillator (ICD)QoL-ICD IINCT06654284
Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Longitudinal Observational Study
An observational study of Implantable Cardioverter Defibrillator (ICD), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Implantable Cardioverter Defibrillator (ICD)
- What is being tested?
- quality of life questionnaires
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Sep 2025to Dec 2042
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with any type of implantable cardioverter-defibrillator implanted and followed at UZ Leuven.
Who may be able to join
- 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.
Who cannot join
- Patients with a mental disability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- quality of life questionnaires
- Keywords
- quality of life, Implantable Cardioverter Defibrillator (ICD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life questionnairesOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
General QoL assessed using the Short Form Health Survey (SF-12)
General QoL assessed using the Short Form Health Survey (SF-12)
The SF-12 measures the experienced health or health-related quality of life. The SF-12 is a shortened version of the longer SF-36. This questionnaire consists of twelve items, divided into eight subcategories:
- General Health
- Physical Functioning
- Role Physical
- Role Emotional
- Bodily Pain
- Mental Health
- Vitality
- Social functioning For each subcategory, a score between 0 and 100 is calculated using an available key. This score can then be compared to an available normative population. Average values below 50 indicate poorer physical/mental health compared to that normative population, while values above 50 indicate better health.
Measured: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
Secondary outcomes (5)
- Cardiac-specific QoL assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
The KCCQ-12 is a shortened, but validated version of the KCCQ-23, and measures symptoms, physical and social limitations, and quality of life in patients with heart failure.2 The 12 questions have variable answer options, but all are based on a Likert scale. KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Measured: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
Florida Shock Acceptance score (FSAS)
Florida Shock Acceptance score (FSAS) The FSAS is intended to measure ICD shock anxiety.4 The measure was designed by an interdisciplinary team including electrophysiology and clinical psychology. Items were based on clinical experience with ICD patients. The scale itself consists of 10 items which respondents rate on a five-point Likert scale ranging from 1 (not at all) to 5 (all of the time). The score of the FSAS is determined by summing the items with higher values representing greater shock anxiety and lower values representing lower shock anxiety.
Measured: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
ICD acceptance assessed using the Florida Patient Acceptance Survey (FPAS)
The primary endpoint of the cross-sectional QoL-ICD study is the ICD acceptance assessed using the Florida Patient Acceptance Survey (FPAS). The FPAS began as a self-report survey with 47 items composed with the help of experts on psychosocial functioning in device patients, an expert in the field of psychometrics, and a cardiac electrophysiologist.2 Information obtained through surveys and interviews were used as guidelines for item construction. The result is an 18 question survey. Of these 18 questions, there are 3 filler items which are still relevant for ICD patients and the remaining questions cover 4 domains: (1) Return to Function; (2) Device-Related Distress; (3) Positive Appraisal; and (4) Body Image Concerns. Items are rated on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). Scale scores were calculated for each of the factors. By combining the scores for each question, a total FPAS score can be calculated.
Measured: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
Steinke Sexual Concerns Inventory
Steinke Sexual Concerns Inventory (SSCI, general cardiac version) The SSCI is an instrument that consists of 9 items reflecting change in the sexual relationship, sexual fears, change in sexual interest, symptoms associated with sexual activity, sexual dysfunction and any other sexual concerns.5 The items are rated on a scale of 0 to 3, where 0 indicates 'never' and 3 indicates 'frequently'. Higher scores indicate greater sexual concerns. Based on previous research, three potential subscales (sexual fears, symptoms, sexual dysfunction) were identified among the items.
Measured: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
"Concept of a Good Death" questionnaire
The Concept of a Good Death measures three distinct domains, reflecting the psychosocial/spiritual, physical, and clinical aspects of a good death. The surveys comprises 17 questions on a 4-point Likert scale ranging from 'not at all' to 'essential'.
Measured: baseline, 3 months, 1 year, 3 years, 6 years, 9 years, adn 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start18 Sep 2025
- Primary completionDec 2042 (estimated)
- Study completionDec 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implantable Cardioverter Defibrillator (ICD)Studies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654284
- Sponsor's protocol ID
- S69418
- Acronym
- QoL-ICD II
- Status last verified
- Nov 2025
- First submitted
- 21 Oct 2024
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Reported Quality of Life in Patients With an Implantable-Cardioverter Defibrillator - A Longitudinal Observational Study
- ClinicalTrials.gov ID
- NCT06654284
- Acronym / sponsor ID
- QoL-ICD II / S69418
- Keywords
- quality of life, Implantable Cardioverter Defibrillator (ICD)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- Dec 2042 (estimated)
- Study completion
- Dec 2042 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with any type of implantable cardioverter-defibrillator implanted and followed at UZ Leuven.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with a mental disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality of life questionnairesAll 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 | Other | – |
Primary outcome
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
General QoL assessed using the Short Form Health Survey (SF-12) The SF-12 measures the experienced health or health-related quality of life. The SF-12 is a shortened version of the longer SF-36. This questionnaire consists of twelve items, divided into eight subcategories: - General Health * Physical Functioning * Role Physical * Role Emotional * Bodily Pain * Mental Health * Vitality * Social functioning For each subcategory, a score between 0 and 100 is calculated using an available key. This score can then be compared to an available normative population. Average values below 50 indicate poorer physical/mental health compared to that normative population, while values above 50 indicate better health.
5 secondary outcomes
- 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implantable Cardioverter Defibrillator (ICD), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.