NCT03371524

A Prospective RegistrY of Cardiac Echographic Loops

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Cardiawave SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Calcified Aortic Valve

Interventions

Type	Name	Description
OTHER	Cardiac Echography	While routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded.

Timeline

• Start date: 2017-07-19
• Primary completion: 2019-01-15
• Completion: 2019-02-01
• First posted: 2017-12-13
• Last updated: 2021-10-05

Locations

3 sites across 1 country: France