Clinical Data Collection and Evaluation of ECG-Less Cardiac CT

General Electric (GE)

Status: Completed

Conditions: Cardiac CT

Treatments: Device: ECG-Less Cardiac CT using SmartPhase

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05949138

11771729874

Details and patient eligibility

About

The primary objective of this study is to collect CT scan data without ECG-leads attached to the human subject. This data is intended to represent a typical range of clinical scenarios in which Cardiac CT imaging is used.

Full description

Data collected in this study will be used for technology development, scientific evaluation, marketing and education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single arm data collection clinical study conducted at one site in the United States of America.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects may be included in this study if they meet the following criteria:

1. Who are 18 year of age or older;
2. Able to sign and date the informed consent form; AND
3. Who are scheduled for a clinical-indicated Cardiac CT exam that will include contrast administration.

Exclusion criteria

Subjects may be excluded from participating in study if they meet any of the following criteria:

1. Who are pregnant or lactating;
2. Who were previously enrolled in this study;
3. Anyone with known or suspected allergy to iodinated contrast agents;
4. Anyone with known or suspected renal insufficiency as determined by site medical personnel;
5. Who are scheduled for a CT cardiac calcium scoring test;
6. Who are in need of urgent or emergent care;
7. Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; AND
8. Who are unwilling to have GEHC personnel present for the CT exam.

Trial design

56 participants in 1 patient group

ECG-Less Cardiac CT

Description:

Enrolled subjects will receive a clinically-indicated, diagnostic Cardiac CT with contrast. No ECG leads will be applied.

Treatment:

Device: ECG-Less Cardiac CT using SmartPhase