NCT05949138

Clinical Data Collection and Evaluation of ECG-Less Cardiac CT

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cardiac CT

Interventions

Type	Name	Description
DEVICE	ECG-Less Cardiac CT using SmartPhase	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.

Timeline

• Start date: 2023-09-11
• Primary completion: 2023-11-01
• Completion: 2023-11-03
• First posted: 2023-07-17
• Last updated: 2024-06-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study