Implantable Cardioverter Defibrillator (ICD)QoLICD-INSIGHTNCT07258602
In-depth Interviews of Patients With ICDs
An observational study of Implantable Cardioverter Defibrillator (ICD), run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Although ICDs are effective in preventing sudden cardiac death, they can also profoundly affect patients' and partner/caregivers' emotional well-being, social relationships, and daily functioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Implantable Cardioverter Defibrillator (ICD)
- What is being tested?
- semi-structured interview
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Nov 2025to Jan 2027
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with any type of implantable cardioverter-defibrillator followed at UZ Leuven and their partners or primary caregivers.
Who may be able to join
- Adult (≥18 years) with an implanted ICD for either primary or secondary prevention of sudden cardiac death.
- At least 3 months have passed since ICD implantation.
- Sufficient cognitive ability and fluency in Dutch to provide informed consent and actively participate in the interview.
- Willing and able to participate in a one-time, individual in-depth interview of 30 to 60 minutes.
Who cannot join
- Current active severe psychiatric disorder or cognitive impairment that would interfere with meaningful participation as based on the medical history..
- Inability to provide informed consent due to legal, cognitive, or communicative limitations.
- Medical instability or terminal illness that, in the opinion of the treating physician or research team, precludes participation.
- Participation in another interventional trial that may influence psychological or behavioral outcomes relevant to this study.
- Participation in the QoL-ICD II trial with longitudinal QoL assessment.
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
Official title: In-depth Interviews to Explore Patient and Partner/Caregiver Experiences, Unmet Needs, and Care Barriers in Patients With Implantable Cardioverter-defibrillators
Although ICDs are effective in preventing sudden cardiac death, they can also profoundly affect patients' and partner/caregivers' emotional well-being, social relationships, and daily functioning. Previous phases of the QoL-ICD project used patient-reported outcome measures (PROMs) and support group discussions to identify key domains affecting quality of life: patient education, physical health, psychological and social well-being, and end-of-life awareness. However, these methods have limitations in capturing the full depth and context of lived experience.
To complement and expand on these findings, this study uses in-depth, semi-structured interviews to explore how ICD patients and their partners interpret and navigate these challenges in their own words. Interviews provide a richer understanding of personal experiences, unmet needs, and barriers to care that are not easily measurable through questionnaires alone. Including both patients and their partners offers insight into relational dynamics and caregiving perspectives.
Read more
The primary objective of this study is to explore the lived experiences of ICD patients and their partners across four key domains:
- Patient education and information provision
- Physical health and activity
- Psychological and social well-being
- End-of-life considerations
Read the detailed description
The investigators will ensure purposive sampling across key demographic and clinical variables which are available after a participant has expressed interest in the trial, with a minimum of 15 participants with ICD per subgroup (e.g., sex, age category, underlying cardiac condition). Data collection will continue until thematic saturation is reached within the overall cohort, followed by at least 5 additional interviews to confirm stability of themes. Subgroup representation is intended to capture relevant variation in lived experience and ensure applicability of findings across the ICD population. There is no subgroup analysis scheduled for partners as this cohort is considered secondary.
Predefined subgroups of interest:
- Sex
- Age: <35 years; 35 to 65 years; and > 65 years
- Underlying cardiac condition: congenital heart disease, hypertrophic cardiomyopathy, primary arrhythmia syndromes, Ischemic cardiomyopathy, Non-ischemic cardiomyopathy
- ICD shock history: appropriate ICD shock; inappropriate ICD shock; none
- Time since implantation: cut-off at 2 years
- ICD indication: primary vs secondary prevention
- Device type: single/dual/S-ICD vs cardiac resynchronization therapy
- Being tested
- semi-structured interview
- 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.
semi-structured interviewOther
Patients with an ICD and partner/caregivers will be invited for semi-structured interviews interviews to explore how ICD patients and their partners/caregivers interpret and navigate these challenges in their own words. Interviews provide a richer understanding of personal experiences, unmet needs, and barriers to care that are not easily measurable through questionnaires alone. Including both patients and their partners offers insight into relational dynamics and caregiving perspectives.
What is being measured
The primary outcome is the main question the study is designed to answer.
Thematic saturation across interviews of the 4 predefined domains
This qualitative study has descriptive and thematic endpoints, not statistical. The primary endpoint is defined as thematic saturation across interviews regarding 4 predefined domains: patient education and information provision, physical health and activity, psychological and social well-being, and end-of-life considerations. Thematic saturation indicates that the data collected sufficiently captures the full range of relevant experiences, perspectives, and needs of ICD patients and their partners. To track thematic saturation a saturation grid and theme tracking table will be used.
A saturation grid tracks the appearance of themes and documents: (1) themes present in each interview; (2) when new themes emerge; (3) when previously identified themes are reinforced. Theme tracking tables summarize the progress by coding the number of new themes. Thematic saturation is reached when 5 consecutive interviews fail to produce any new themes after a minimum of 15 interviews per subgroup.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start4 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (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
- Cross-sectional
- Enrolment
- 250 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
- NCT07258602
- Sponsor's protocol ID
- S71109
- Acronym
- QoLICD-INSIGHT
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-depth Interviews to Explore Patient and Partner/Caregiver Experiences, Unmet Needs, and Care Barriers in Patients With Implantable Cardioverter-defibrillators
- ClinicalTrials.gov ID
- NCT07258602
- Acronym / sponsor ID
- QoLICD-INSIGHT / S71109
- Keywords
- quality of life, implantable cardioverter defibrillator (ICD)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Dec 2025 (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.
Although ICDs are effective in preventing sudden cardiac death, they can also profoundly affect patients' and partner/caregivers' emotional well-being, social relationships, and daily functioning. Previous phases of the QoL-ICD project used patient-reported outcome measures (PROMs) and support group discussions to identify key domains affecting quality of life: patient education, physical health, psychological and social well-being, and end-of-life awareness. However, these methods have limitations in capturing the full depth and context of lived experience.
To complement and expand on these findings, this study uses in-depth, semi-structured interviews to explore how ICD patients and their partners interpret and navigate these challenges in their own words. Interviews provide a richer understanding of personal experiences, unmet needs, and barriers to care that are not easily measurable through questionnaires alone. Including both patients and their partners offers insight into relational dynamics and caregiving perspectives.
The primary objective of this study is to explore the lived experiences of ICD patients and their partners across four key domains:
- Patient education and information provision
- Physical health and activity
- Psychological and social well-being
- End-of-life considerations
Detailed description
The investigators will ensure purposive sampling across key demographic and clinical variables which are available after a participant has expressed interest in the trial, with a minimum of 15 participants with ICD per subgroup (e.g., sex, age category, underlying cardiac condition). Data collection will continue until thematic saturation is reached within the overall cohort, followed by at least 5 additional interviews to confirm stability of themes. Subgroup representation is intended to capture relevant variation in lived experience and ensure applicability of findings across the ICD population. There is no subgroup analysis scheduled for partners as this cohort is considered secondary.
Predefined subgroups of interest:
- Sex
- Age: <35 years; 35 to 65 years; and > 65 years
- Underlying cardiac condition: congenital heart disease, hypertrophic cardiomyopathy, primary arrhythmia syndromes, Ischemic cardiomyopathy, Non-ischemic cardiomyopathy
- ICD shock history: appropriate ICD shock; inappropriate ICD shock; none
- Time since implantation: cut-off at 2 years
- ICD indication: primary vs secondary prevention
- Device type: single/dual/S-ICD vs cardiac resynchronization therapy
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with any type of implantable cardioverter-defibrillator followed at UZ Leuven and their partners or primary caregivers.
Key inclusion criteria (4 listed)
- Adult (≥18 years) with an implanted ICD for either primary or secondary prevention of sudden cardiac death.
- At least 3 months have passed since ICD implantation.
- Sufficient cognitive ability and fluency in Dutch to provide informed consent and actively participate in the interview.
- Willing and able to participate in a one-time, individual in-depth interview of 30 to 60 minutes.
Key exclusion criteria (5 listed)
- Current active severe psychiatric disorder or cognitive impairment that would interfere with meaningful participation as based on the medical history..
- Inability to provide informed consent due to legal, cognitive, or communicative limitations.
- Medical instability or terminal illness that, in the opinion of the treating physician or research team, precludes participation.
- Participation in another interventional trial that may influence psychological or behavioral outcomes relevant to this study.
- Participation in the QoL-ICD II trial with longitudinal QoL assessment.
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 |
|---|---|---|
| semi-structured interviewPatients with an ICD and partner/caregivers will be invited for semi-structured interviews interviews to explore how ICD patients and their partners/caregivers interpret and navigate these challenges in their own words. Interviews provide a richer understanding of personal experiences, unmet needs, and barriers to care that are not easily measurable through questionnaires alone. Including both patients and their partners offers insight into relational dynamics and caregiving perspectives. | Other | – |
Primary outcome
Thematic saturation across interviews of the 4 predefined domains
Time frame: 1 year
This qualitative study has descriptive and thematic endpoints, not statistical. The primary endpoint is defined as thematic saturation across interviews regarding 4 predefined domains: patient education and information provision, physical health and activity, psychological and social well-being, and end-of-life considerations. Thematic saturation indicates that the data collected sufficiently captures the full range of relevant experiences, perspectives, and needs of ICD patients and their partners. To track thematic saturation a saturation grid and theme tracking table will be used. A saturation grid tracks the appearance of themes and documents: (1) themes present in each interview; (2) when new themes emerge; (3) when previously identified themes are reinforced. Theme tracking tables summarize the progress by coding the number of new themes. Thematic saturation is reached when 5 consecutive interviews fail to produce any new themes after a minimum of 15 interviews per subgroup.
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 2 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 4 inclusion and 5 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 2 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?
Thematic saturation across interviews of the 4 predefined domains (time frame: 1 year). 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 2 Dec 2025.