A Prospective RegistrY of Cardiac Echographic Loops
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Validation of the 'valve tracking' processing algorithm of CARDIAWAVE.
研究概览
简要总结
CARDIAWAVE, a French start-up founded in 2014, aims to develop a new non-invasive therapy to treat patients suffering from Aortic Valve Stenosis (AS) who are not candidates to validated treatment of AS, i.e. TAVI (Transcatheter Aortic Valve Implantation) or SAVR (Surgical Aortic Valve Replacement). This therapy consists in focusing ultrasound on aortic valve transthoracically and use high energy to soften calcification from the target valve. In order to do so, we develop a device able to deliver high energy ultrasounds to a targeted valve thanks to the synchronization of patient hearts live imaging and therapy in real time.
Live imaging will use an algorithm to realize 'valve tracking': an automatic detection of aortic valve position and shape as fast as image acquisition time. In order to develop and validate this 'valve tracking' algorithm, CARDIAWAVE requires cardiac echographic loops of patients with aortic valve calcification, with 30 seconds or 60 seconds recording.
The objective of the present study is to develop and validate the 'valve tracking' processing algorithm of CARDIAWAVE.
ARYEL is a prospective, multicenter, non-interventional study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients aged ≥ 18 y.o
- •Patients with a confirmed diagnosis of Aortic valve calcification on native valve or bioprosthesis
- •Patients with planned cardiac transthoracic echography for 'Aortic valve calcification' follow-up
- •Patients who have signed Informed Consent Form
- •Patients affiliated to French social security or equivalent
排除标准
- •Patients allergic to echographic gel
- •Patients with "hostile thorax": serious cutaneous irradiation injury or major thoracic deformity.
- •Low echogenicity
- •Patients with mild or high abundance pericardic effusion
结局指标
主要结局
Validation of the 'valve tracking' processing algorithm of CARDIAWAVE.
时间窗: Through study completion, up to 6 months
次要结局
未报告次要终点
