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RecruitingNCT05868902

A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.

Status
Recruiting
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Genetesis Inc. · Industry
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

Summary

A multicenter observational data development registry collecting diagnostic measures via standard of care (SOC) cardiac PET in order gain a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia.

Conditions

Interventions

TypeNameDescription
DEVICECardioFlux MagnetocardiographyThe device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software. CardioFlux devices are owned by Genetesis and are currently cleared for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity (K182571, FDA clearance letter available for download online)

Timeline

Start date
2023-08-28
Primary completion
2025-06-01
Completion
2025-12-31
First posted
2023-05-22
Last updated
2025-02-20

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05868902. Inclusion in this directory is not an endorsement.

A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia. (NCT05868902) · Clinical Trials Directory