Not_yet_recruitingNCT07557147

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)

Sponsor: Bayer

Trial Details

ConditionTransthyretin Amyloid Cardiomyopathy (ATTR-CM)
InterventionLuscii
StatusNot_yet_recruiting
Participants60
Est. Completion22 Nov 2027
Last Updated11 June 2026

Primary Outcome

Acceptance of Luscii among medical professionals; Acceptance of Luscii among participants with ATTR-CM; Feasibility of Luscii for medical professionals; Feasibility of Luscii for participants with ATTR-CM; Self-reported acceptance and feasibility of the ATTR-CM-specific Luscii configuration among participants; Self-reported acceptance and feasibility of the ATTR-CM-specific Luscii configuration among medical professionals

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Trial Sites

🇦🇺 Australian Sites (1)

Countries

AustriaGermanyItaly
View Registry Entry

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