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临床试验/NCT03371524
NCT03371524已完成不适用

A Prospective RegistrY of Cardiac Echographic Loops

Cardiawave SA3 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Cardiawave SA
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

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

研究者

发起方
Cardiawave SA
申办方类型
Industry
责任方
Sponsor

研究点 (3)

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