Transthyretin Amyloid Cardiomyopathy (ATTR-CM)ACO-MONITORNCT07557147
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 of Transthyretin Amyloid Cardiomyopathy (ATTR-CM), run by Bayer at 3 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
- What is being tested?
- Luscii
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 30 Oct 2026to 15 May 2028
- 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: Eligible participants will be invited by their treating physician and, after providing informed consent, will be observed for approx. 12 months. Patients with an established diagnosis of either wild-type or variant ATTR-CM can be enrolled. Evidence of assessment of all eligibility criteria by the physician or a delegate, as well as enrolment of a participant in the study should be documented in the participant medical records. Medical professionals who are directly involved in the participants' treatment and who have access to and will review the Luscii-captured data for routine care are asked to complete the study-specific questionnaires/forms.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
About this study
Official title: 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)
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.
Read more
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.
- Being tested
- Luscii
- Keywords
- Remote monitoring, Digital health, ATTR-CM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LusciiDevice
The Luscii tool (CE class IIa certification) will be utilized for remote monitoring of health data specific to ATTR-CM patients. Following the observational nature of the study, no additional interventions will be implemented beyond the standard use of the Luscii tool. Participants will use the Luscii tool continuously throughout the observational period, which is approximately 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Wild-type or variant ATTR-CM participants | Participants will be enrolled after the decision to initiate the use of the digital remote monitoring tool, Luscii, as per standard use. Receives: Device: Luscii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of Luscii among medical professionals
Defined as their willingness to adopt and engage with the ATTR-CM-specific configuration of Luscii vitals and Luscii contact throughout the study period.
Measured: At baseline (initial visit), at 6 months and at 12 months
Acceptance of Luscii among participants with ATTR-CM
Defined as their willingness to adopt and engage with the ATTR-CM-specific configuration of Luscii contact throughout the observational period.
Measured: At baseline (initial visit), at 6 months and at 12 months
Feasibility of Luscii for medical professionals
Defined as the practicality of implementing the tool in real-world ATTR-CM care throughout the study period.
Measured: At baseline (initial visit), at 6 months and at 12 months
Feasibility of Luscii for participants with ATTR-CM
Defined as the practicality of using the tool in real-world settings throughout the observational period.
Measured: At baseline (initial visit), at 6 months and at 12 months
Self-reported acceptance and feasibility of the ATTR-CM-specific Luscii configuration among participants
Measured by the Patient Experience Questionnaire
Measured: At baseline (initial visit), at 6 months and at 12 months
Self-reported acceptance and feasibility of the ATTR-CM-specific Luscii configuration among medical professionals
Measured by the Healthcare Professional (HCP) Experience Questionnaire
Measured: At baseline (initial visit), at 6 months and at 12 months
Secondary outcomes (9)
Participant demographic characteristics: age
Demographic characteristics of participants with ATTR-CM who are willing to use a digital remote tool at baseline (initial visit)
Measured: At baseline (initial visit)
Participant demographic characteristics: sex
Demographic characteristics of participants with ATTR-CM who are willing to use a digital remote tool at baseline
Measured: At baseline (initial visit)
Participant demographic characteristics: race
Demographic characteristics of participants with ATTR-CM who are willing to use a digital remote tool at baseline
Measured: At baseline (initial visit)
Clinical characteristics: National Amyloidosis Centre (NAC) Stage
Categorization of participants according to the NAC Stage into stages I, II, or III, with stage III indicating a higher risk of mortality
Measured: At baseline (initial visit)
Clinical characteristics: relevant comorbidities
ATTR-CM relevant comorbidities
Measured: At baseline (initial visit)
Number of patients who failed screening
Measured: At baseline (Initial visit)
Reason for screening failure
Measured: At baseline (Initial visit)
Treatment patterns with Acoramidis: ATTR-CM prior medications
Concomitant medications administered within the past 12 months before initial visit
Measured: At baseline (initial visit)
Treatment patterns with Acoramidis: ATTR-CM concomitant medications
Previously administered ATTR-CM related medications within the past 12 months before initial visit
Measured: At baseline (initial visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start30 Oct 2026 (estimated)
- Primary completion15 Apr 2028 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)Studies of the same condition, open and under way.
- More trials run by BayerThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557147
- Sponsor's protocol ID
- 23127
- Acronym
- ACO-MONITOR
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07557147
- Acronym / sponsor ID
- ACO-MONITOR / 23127
- Keywords
- Remote monitoring, Digital health, ATTR-CM
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 29 Apr 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wild-type or variant ATTR-CM participants | – | Device: LusciiParticipants will be enrolled after the decision to initiate the use of the digital remote monitoring tool, Luscii, as per standard use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be invited by their treating physician and, after providing informed consent, will be observed for approx. 12 months. Patients with an established diagnosis of either wild-type or variant ATTR-CM can be enrolled. Evidence of assessment of all eligibility criteria by the physician or a delegate, as well as enrolment of a participant in the study should be documented in the participant medical records. Medical professionals who are directly involved in the participants' treatment and who have access to and will review the Luscii-captured data for routine care are asked to complete the study-specific questionnaires/forms.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Any current affiliation with Luscii, Bayer, or any of their affiliates.
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 |
|---|---|---|
| LusciiThe Luscii tool (CE class IIa certification) will be utilized for remote monitoring of health data specific to ATTR-CM patients. Following the observational nature of the study, no additional interventions will be implemented beyond the standard use of the Luscii tool. Participants will use the Luscii tool continuously throughout the observational period, which is approximately 12 months. | Device | Wild-type or variant ATTR-CM participants |
Primary outcome
Acceptance of Luscii among medical professionals
Time frame: At baseline (initial visit), at 6 months and at 12 months
Defined as their willingness to adopt and engage with the ATTR-CM-specific configuration of Luscii vitals and Luscii contact throughout the study period.
Acceptance of Luscii among participants with ATTR-CM
Time frame: At baseline (initial visit), at 6 months and at 12 months
Defined as their willingness to adopt and engage with the ATTR-CM-specific configuration of Luscii contact throughout the observational period.
Feasibility of Luscii for medical professionals
Time frame: At baseline (initial visit), at 6 months and at 12 months
Defined as the practicality of implementing the tool in real-world ATTR-CM care throughout the study period.
Feasibility of Luscii for participants with ATTR-CM
Time frame: At baseline (initial visit), at 6 months and at 12 months
Defined as the practicality of using the tool in real-world settings throughout the observational period.
Self-reported acceptance and feasibility of the ATTR-CM-specific Luscii configuration among participants
Time frame: At baseline (initial visit), at 6 months and at 12 months
Measured by the Patient Experience Questionnaire
Self-reported acceptance and feasibility of the ATTR-CM-specific Luscii configuration among medical professionals
Time frame: At baseline (initial visit), at 6 months and at 12 months
Measured by the Healthcare Professional (HCP) Experience Questionnaire
9 secondary outcomes
Participant demographic characteristics: age
Time frame: At baseline (initial visit)
Participant demographic characteristics: sex
Time frame: At baseline (initial visit)
Participant demographic characteristics: race
Time frame: At baseline (initial visit)
Clinical characteristics: National Amyloidosis Centre (NAC) Stage
Time frame: At baseline (initial visit)
Clinical characteristics: relevant comorbidities
Time frame: At baseline (initial visit)
Number of patients who failed screening
Time frame: At baseline (Initial visit)
Reason for screening failure
Time frame: At baseline (Initial visit)
Treatment patterns with Acoramidis: ATTR-CM prior medications
Time frame: At baseline (initial visit)
Treatment patterns with Acoramidis: ATTR-CM concomitant medications
Time frame: At baseline (initial visit)
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 26 Oct 2026.
- Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transthyretin Amyloid Cardiomyopathy (ATTR-CM), run by Bayer at 3 sites in 3 countries.
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 9 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: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany, Italy. 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?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of Luscii among medical professionals (time frame: At baseline (initial visit), at 6 months and at 12 months). The study lists 6 primary outcomes in all. 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 26 Oct 2026.