Clinical Data Collection and Evaluation of ECG-Less Cardiac CT

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Data Collection and Evaluation of ECG-Less Cardiac CT

Conditions
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Cardiac CT

Intervention / Treatment
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* Device: ECG-Less Cardiac CT using SmartPhase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects may be included in this study if they meet the following criteria: Who are 18 year of age or older; Able to sign and date the informed consent form; AND 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: Who are pregnant or lactating; Who were previously enrolled in this study; Anyone with known or suspected allergy to iodinated contrast agents; Anyone with known or suspected renal insufficiency as determined by site medical personnel; Who are scheduled for a CT cardiac calcium scoring test; Who are in need of urgent or emergent care; 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 Who are unwilling to have GEHC personnel present for the CT exam.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECG-Less Cardiac CT<br>Enrolled subjects will receive a clinically-indicated, diagnostic Cardiac CT with contrast. No ECG leads will be applied. | Device: ECG-Less Cardiac CT using SmartPhase<br>* Administration of medications and biologic products (such as contrast agent administration, and potentially beta-blockers and other medications) will be given according to standard hospital care. This is a prospective research study evaluating an investigational workflow on an existing CT device that has regulatory clearance. The investigational workflow includes preforming the CT acquisition according to the hospital's usual care with the exception that the ECG signal which triggers the scan will be coming from an ECG simulator based on an estimate of the patient's heart rate, rather than through ECG leads connected to the subject. Clinically-indicated Cardiac CTs take approximately 30-60 minutes. No additional imaging is needed as part of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data Collection | Number of Participants with raw investigational cardiac CT scan data | Through study completion, an average of 6 months |