A Study Of MCG In Cardiac Amyloidosis

Mayo Clinic

Status: Enrolling

Conditions: Amyloidosis

Treatments: Device: SandboxAQ CardiAQ Magnetocardiography

Study type: Observational

Funder types: Other

Identifiers

NCT07218705

25-005053

Details and patient eligibility

About

The primary objective of this observational study is to evaluate the utility of magnetocardiography (MCG) in diagnosing and monitoring disease progression in patients with amyloidosis, and to assess its effectiveness in comparison to other modalities, such as ECG.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Age ≥ 18 years on the date of consent
2. Ability for participant to comply with study requirements
3. Written informed consent

Exclusion Criteria

1. Pregnant or breastfeeding
2. Having an active atrial fibrillation episode as seen on most current 12-lead ECG
3. Active thoracic metal implants (including pacemaker, insertable cardiac monitor, or internal defibrillator).
4. External electrical pads or devices (e.g. Pacer pads, ECG electrodes, heart rate patch), that must remain on patient's chest during MCG scan
5. Inability to lie down in a supine/inclined position and stay still on the examination bed
6. Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol

Trial design

500 participants in 1 patient group

Patients with amyloidosis

Treatment:

Device: SandboxAQ CardiAQ Magnetocardiography