About this trial
This study investigates the clinical efficacy of a non-invasive screening protocol using AI-ECG and CT-ECV analysis for cardiac amyloidosis. The study targets on atrial fibrillation(AF) patients with "red-flag" indicators.
Participants are randomized 1:1 into either an early screening or usual care group.
* Early screening group : AI- ECG and/or CT-ECV analysis + AF treatment * Usual care group : AF treatment Both groups followed for 2 years to compare CA detection rates and clinical outcomes.
Eligibility criteria
Qualifiers
Adults aged 19 or older who have provided voluntary written informed consent.
Patients with a history of AF (paroxysmal or persistent) and one or more red-flag symptoms/signs.
Patients who can undergo at least one of the following: AI-ECG analysis or CT-ECV analysis.
Disqualifiers
Patients previously diagnosed with cardiac amyloidosis (AL or ATTR).
Patients with severe heart failure (NYHA class IV) or terminal illness with a life expectancy of less than 1 year.
Patients deemed inappropriate for participation by the investigator.
Trial design
Treatments tested in this trial
- AI-ECG analysis
- CT-ECV analysis
- Atrial fibrillation treatment
Treatment groups
Sponsors and collaborators
Samsung Medical Center
Lead sponsor
Mayo Clinic
Collaborator