A Prospective RegistrY of Cardiac Echographic Loops

NCT ID: NCT03371524

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-19
• Study Completion Date: 2019-02-01

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Native valves_30 seconds loops

Patient with calcified aortic stenosis on native valve: record of a 30 second loop during routine cardiac echography.

Cardiac Echography

Intervention Type: OTHER

While routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded.

Native valves_30 and 60 seconds loops

Patient with calcified aortic stenosis on native valve: record of a 30 second loop and a 60 second loop during routine cardiac echography.

Cardiac Echography

Intervention Type: OTHER

While routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded.

Bioprosthesis_30 seconds loops

Patient with calcified aortic stenosis on bioprosthesis: record of a 30 second loop during routine cardiac echography.

Cardiac Echography

Intervention Type: OTHER

While routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded.

Interventions

Cardiac Echography

While routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardiawave SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Caen

Caen, , France

Hôpital Européen Georges Pompidou

Paris, , France

Hôpital Charles Nicolle

Rouen, , France

Countries

France

Other Identifiers

ARYEL

Identifier Type: -

Identifier Source: org_study_id