Calcified Aortic ValveARYELNCT03371524
A Prospective RegistrY of Cardiac Echographic Loops
An observational study of Calcified Aortic Valve, run by Cardiawave SA at 3 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcified Aortic Valve
- What is being tested?
- Cardiac Echography
- How many people
- 90 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Jul 2017to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosed calcified aortic stenosis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Caen
Caen, 14000
Hôpital Européen Georges Pompidou
Paris, 75015
Hôpital Charles Nicolle
Rouen, 76000
About this study
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.
Read more
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
- Being tested
- Cardiac Echography
- Medical subject headings
- Aortic Valve, Calcification of
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac EchographyOther
While routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded.
| Study group | Role | What they receive |
|---|---|---|
| Native valves_30 seconds loops | Patient with calcified aortic stenosis on native valve: record of a 30 second loop during routine cardiac echography. Receives: Other: Cardiac Echography | |
| 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. Receives: Other: Cardiac Echography | |
| Bioprosthesis_30 seconds loops | Patient with calcified aortic stenosis on bioprosthesis: record of a 30 second loop during routine cardiac echography. Receives: Other: Cardiac Echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the 'valve tracking' processing algorithm of CARDIAWAVE.
Measured: Through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start19 Jul 2017
- Primary completion15 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcified Aortic ValveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiawave SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371524
- Sponsor's protocol ID
- ARYEL
- Acronym
- ARYEL
- Status last verified
- Oct 2021
- First submitted
- 7 Dec 2017
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective RegistrY of Cardiac Echographic Loops
- ClinicalTrials.gov ID
- NCT03371524
- Acronym / sponsor ID
- ARYEL / ARYEL
- Conditions
- Calcified Aortic Valve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cardiawave SAIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Native valves_30 seconds loops | – | Other: Cardiac EchographyPatient with calcified aortic stenosis on native valve: record of a 30 second loop during routine cardiac echography. |
| Native valves_30 and 60 seconds loops | – | Other: Cardiac EchographyPatient with calcified aortic stenosis on native valve: record of a 30 second loop and a 60 second loop during routine cardiac echography. |
| Bioprosthesis_30 seconds loops | – | Other: Cardiac EchographyPatient with calcified aortic stenosis on bioprosthesis: record of a 30 second loop during routine cardiac echography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed calcified aortic stenosis.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac EchographyWhile routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded. | Other | Bioprosthesis_30 seconds loops, Native valves_30 and 60 seconds loops, Native valves_30 seconds loops |
Primary outcome
Validation of the 'valve tracking' processing algorithm of CARDIAWAVE.
Time frame: Through study completion, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Calcified Aortic Valve, run by Cardiawave SA at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the 'valve tracking' processing algorithm of CARDIAWAVE. (time frame: Through study completion, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.