NCT05949138已完成不适用
Clinical Data Collection and Evaluation of ECG-Less Cardiac CT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Data Collection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Data Collection
时间窗: Through study completion, an average of 6 months
Number of Participants with raw investigational cardiac CT scan data
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
终止
不适用
BIO|CONCEPT.ECG-Library (Collection of ECG Signals for Development of Algorithms)Heart DiseasesAbnormal RhythmNCT04243070Biotronik SE & Co. KG89
已完成
不适用
Leadless Electrocardiogram (ECG) Evaluation StudyHeart FailureNCT01297283Medtronic Cardiac Rhythm and Heart Failure195
进行中（未招募）
不适用
GSI Cardiac on Revolution Apex - USCoronary Computed Tomographic AngiographyMyocardial Infarction (MI)Cardiac CatheterizationNCT06702917GE Healthcare50
尚未招募
不适用
12 Lead ECG DatabaseArrhythmias, CardiacNCT06513637Huxley Medical, Inc.150
Unknown
不适用
Data Collection in Patients Undergoing CT-Guided Needle Interventions for NeedleWays System DevelopmentTumorsNCT02329665NeedleWays50