A Prospective RegistrY of Cardiac Echographic Loops

Calcified Aortic Valve Clinical Trial

— ARYEL  

Official title:

A Prospective RegistrY of Cardiac Echographic Loops

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371524
• Other study ID #: ARYEL
• Status: Completed
• Start date: July 19, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: October 2021
• Source: Cardiawave SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 1, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Calcified Aortic Valve

Intervention

Other:
• Cardiac Echography
While routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded.

Locations

Country	Name	City	State
France	CHU de Caen	Caen
France	Hôpital Européen Georges Pompidou	Paris
France	Hôpital Charles Nicolle	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Cardiawave SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of the 'valve tracking' processing algorithm of CARDIAWAVE.		Through study completion, up to 6 months