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| Name | Class |
|---|---|
| University of Chicago | OTHER |
| University of Washington | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECG-Less Cardiac CT | Enrolled subjects will receive a clinically-indicated, diagnostic Cardiac CT with contrast. No ECG leads will be applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG-Less Cardiac CT using SmartPhase | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Data Collection | Number of Participants with raw investigational cardiac CT scan data | Through study completion, an average of 6 months |
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Inclusion Criteria:
Subjects may be included in this study if they meet the following criteria:
Exclusion Criteria:
Subjects may be excluded from participating in study if they meet any of the following criteria:
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The subject population will consist of adults that are 18-years of age or older, and who are scheduled for a clinically indicated cardiac CT exam that will include contrast administration.
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| Name | Affiliation | Role |
|---|---|---|
| Kayla Matcheck | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| University of Washington |
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|
| Seattle |
| Washington |
| 98195 |
| United States |