ClinicalTrials.gov record NCT07557147
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor
An Observational Study to Learn More About How Acceptable and Practical a Digital Remote Monitoring Tool (Luscii) is in People With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study will assess how acceptable and practical the Luscii digital remote monitoring tool is for people with transthyretin amyloid cardiomyopathy (ATTR-CM). About 60 adults with wild-type or hereditary (variant) ATTR-CM will use the Luscii app and devices and be followed for about 12 months; no treatments are given as part of the study. Researchers will collect usage data and ask participants and healthcare professionals to complete experience questionnaires at baseline, 6 months, and 12 months.
What it is studying. Whether people with ATTR-CM and their healthcare professionals will adopt and can practically use the Luscii remote-monitoring system. The study measures use patterns (frequency, duration, response to reminders), self-reported ease of use and acceptance from both patients and healthcare professionals, and records technical issues.
What the researchers hope to learn. To measure acceptance and feasibility of the ATTR-CM-specific Luscii configuration among patients and healthcare professionals; to describe usage patterns and duration of use; to collect self-reported experience via patient and HCP questionnaires; and to record participant demographics, clinical characteristics (including NAC Stage and relevant comorbidities), screening outcomes, and recent ATTR-CM treatment patterns.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Transthyretin amyloid cardiomyopathy (ATTR-CM) is a heart condition caused by a protein called transthyretin (TTR) building up as amyloid in the heart muscle. This build-up makes the heart stiff and can lead to symptoms of heart failure, such as difficulty breathing, tiredness, swelling in the legs, and reduced ability to be physically active. ATTR-CM occurs in two forms: a hereditary (variant) type caused by changes in genes, and a wild-type form that usually develops with aging. People living with ATTR-CM are usually cared for at specialist centers, which may require them to travel long distances for appointments. Because of this, visits may be infrequent, and sometimes people only see their doctor once a year. This can make it harder to notice if the disease is getting worse or if there are problems with following their treatment plan. As a result, important changes in health may go unnoticed for several months, which can be risky. Remote monitoring offers a way for people living with ATTR-CM and their healthcare professionals to stay connected between clinic visits. Recent studies have shown that remote monitoring can help by making it easier to share health information, spot problems earlier, and support people to follow their treatment plans. This can lead to fewer hospital visits and better health outcomes. Luscii is a digital remote monitoring tool designed to help people living with ATTR-CM and their healthcare professionals stay connected between clinic visits. Luscii has two main parts: Luscii contact, a smartphone app that allows secure messaging and video calls, and Luscii vitals, a clinical software system that organizes health data and can alert the healthcare team if there are changes that need attention. Luscii vitals is a CE-marked medical device used within its approved purpose and does not replace a doctor's judgement. By making it easier to communicate and share information, Luscii aims to support earlier detection of problems, better management of ATTR-CM, and a more positive experience for people living with this condition. The main purpose of this observational study, called ACO-MONITOR, is to learn how acceptable and practical Luscii is for people living with ATTR-CM and their healthcare professionals. The study will take place in Austria, Germany, and Italy at three specialist centers. About 60 adults with a diagnosis of hereditary or wild-type ATTR-CM will be invited to take part. There will be no treatments given as part of this study. Instead, participants will use the Luscii app and devices at home to track their health and share information with their healthcare professionals. The study team will provide training on how to use Luscii and will help participants get started. The study team will look at:
- How quickly and how often participants and healthcare professionals use Luscii
- How long Luscii is used by each person
- How many times participants use Luscii after being reminded
- How easy Luscii is to use, based on questionnaires for both participants and healthcare professionals
The study will last about 18 months in total, including a 6-month period to invite participants and a 12-month follow-up period. During the study, the study team will:
- Support participants in using Luscii to share health information from home
- Monitor how often and how easily Luscii is used
- Ask participants and healthcare professionals about their experiences using Luscii, including what worked well and what could be improved
- Record any problems or technical issues with using Luscii By collecting this information, the researchers hope to learn if Luscii can help improve communication, support earlier detection of health problems, and make it easier for people living with ATTR-CM to manage their condition between clinic visits.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Device
- Luscii
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- For patients:
- Adult (≥18 years at the date of signing the informed consent form (ICF)).
- Diagnosis of either wild-type or variant ATTR-CM.
- Treatment with a drug approved for ATTR-CM, including newly prescribed therapy at the initial visit.
- Signed ICF.
- Access to and basic ability to use a personal smartphone with internet connectivity sufficient to install and operate the Luscii contact application.
- For medical professionals:
- Directly involved in the treatment or clinical management of the enrolled ATTR-CM participants and having access to and reviewing the Luscii-captured data for routine care.
- Agreement to ICF within the EDC system for the purpose of using Luscii or to complete the HCP Experience Questionnaire.
Exclusion criteria
- For patients:
- Participation in an investigational program with interventions outside of routine clinical practice.
- Patients who are unable to provide consent, including those whose consent would need to be given by a legal representative.
- For medical professionals:
- Any current affiliation with Luscii, Bayer, or any of their affiliates.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants use the Luscii digital remote-monitoring tool on their smartphone and any related devices at home while continuing their usual care; no additional medical treatments are given as part of the study. The study team provides training and help to get started, and will monitor app use over an observational period of about 12 months with assessments at enrollment, around 6 months, and at 12 months. You will complete experience questionnaires about using Luscii, and the study will collect usage data (how often you use the app, duration of use, responses after reminders) and record any technical problems. Healthcare professionals involved in your care will review Luscii-captured data for routine care and complete their own questionnaires about acceptability and feasibility.
How the study is structured. This is a prospective, single-group observational study (cohort). Participants who start using the Luscii remote-monitoring tool will be followed for about 12 months while the study team collects how often and how long the tool is used and gathers questionnaire feedback from both patients and their healthcare professionals. No experimental treatments are assigned; the study observes real-world use of Luscii with measurements at baseline, 6 months, and 12 months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Transthyretin Amyloid Cardiomyopathy (ATTR-CM). Does it apply to my diagnosis?
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in Austria, Germany, Italy. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
Important dates
- Study start
- Oct 15, 2026 (estimated)
- Primary completion
- Apr 15, 2028 (estimated)
- Study completion
- May 15, 2028 (estimated)
- Target enrollment
- 60 participants (estimated)
- Last updated on registry
- Sep 24, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Bayer
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Bayer Clinical Trials Contact 📞 (+)1-888-84 22937 ✉ clinical-trials-contact@bayer.com
Participating sites (3)
- Medizinische Universität Innsbruck
Innsbruck, 6020 · Austria
- Universitätsklinikum Heidelberg
Heidelberg, 69120 · Germany
- Policlinico San Matteo di Pavia
Pavia, 27100 · Italy
Terms used on this page · explanations by MedicalUpdates.ai
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- legal representative
- A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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