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Heart device patients share hidden struggles in new study

NCT ID NCT07258602

Knowledge-focused Sponsor: Universitaire Ziekenhuizen KU Leuven Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study uses in-depth interviews to explore how people with implantable cardioverter-defibrillators (ICDs) and their partners cope emotionally, socially, and physically. Researchers aim to uncover unmet needs and barriers to care that surveys often miss. By talking directly to 250 patients and caregivers, they hope to improve education, support, and end-of-life planning for those living with these life-saving devices.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could reveal hidden challenges faced by ICD patients and their caregivers, pointing toward better support and education programs.
What could go wrong
This is a small, early-stage interview study, not a treatment trial. Findings may not apply to all ICD patients or lead to direct changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with any type of implantable cardioverter-defibrillator followed at UZ Leuven and their partners or primary caregivers.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Implantable cardioverter defibrillator (ICD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UZ Leuven

    Leuven, 3000, Belgium

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