Mitral Valve DiseaseARTERYNCT04787757
Autonomous Robotics for Transcatheter Cardiac Procedures
An observational study of Mitral Valve Disease and Heart Valve Diseases, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
Cardiovascular diseases represent the most common cause of death worldwide. Percutaneous approaches with intravascular catheters are pivotal, since they allow to treat patients with high perioperative risks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Disease, Heart Valve Diseases, Structural Heart Abnormality
- What is being tested?
- Percutaneous cardiac procedure
- Type of treatment
- Surgery or procedure
- How many people
- 401 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2021to 21 Jun 2024
- 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: Candidates to percutaneous cardiac defects repair
Who may be able to join
- adult patients
- patients admitted to hospital undergoing percutaneous cardiac procedure
- patients able to give informed consent
Who cannot join
- age <18 years
- refuse to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autonomous Robotics for Transcatheter dEliveRy sYstems
Cardiovascular diseases represent the most common cause of death worldwide. Percutaneous approaches with intravascular catheters are pivotal, since they allow to treat patients with high perioperative risks. However, catheter-based treatments require steep learning curves and are characterized by poor ergonomics and exposure to damaging radiation. ARTERY will offer a radiation-free approach based on shared-autonomy robotic catheters, with increased user engagement and easy interaction. Intraprocedural three-dimensional echocardiography as well as computed tomography images obtained during usual clinical practice will provide artificial intelligence algorithms that will turn catheter navigation to a simple task. Optical and electromagnetic sensing techniques will ensure a superior view upon the cardiovascular anatomy and will guide the autonomous catheter upon the interventionist supervision, who will be able to take over control at any instant.
- Being tested
- Percutaneous cardiac procedure
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous cardiac procedureProcedure or surgery
Collection and analysis of intraprocedural information to provide artificial intelligence algorithms
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous cardiac procedures | Patients undergoing percutaneous cardiac procedures Receives: Procedure: Percutaneous cardiac procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of key procedural elements that will benefit from the technological developments introduced by ARTERY by collecting intraprocedural images
Number of patients undergoing percutaneous cardiac procedures
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start15 Mar 2021
- Primary completion21 May 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, KU Leuven, SwissVortex, Artiness SRL, FBGS, IRCCS Ospedale San Raffaele
- Responsible party
- Principal investigator, Giovanni Landoni, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787757
- Sponsor's protocol ID
- ARTERY/08/2021
- Acronym
- ARTERY
- Status last verified
- Aug 2025
- First submitted
- 26 Feb 2021
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Munafo R, Saitta S, Tondi D, Ingallina G, Denti P, Maisano F, Agricola E, Votta E. Automatic 4D mitral valve segmentation from transesophageal echocardiography: a semi-supervised learning approach. Med Biol Eng Comput. 2025 Jan 11. doi: 10.1007/s11517-024-03275-w. Online ahead of print.
PubMed 39797996
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomous Robotics for Transcatheter dEliveRy sYstems
- ClinicalTrials.gov ID
- NCT04787757
- Acronym / sponsor ID
- ARTERY / ARTERY/08/2021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Collaborators
- Politecnico di Milano, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, KU Leuven, SwissVortex, Artiness SRL, FBGS, IRCCS Ospedale San Raffaele
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 9 Mar 2021 (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.
Cardiovascular diseases represent the most common cause of death worldwide. Percutaneous approaches with intravascular catheters are pivotal, since they allow to treat patients with high perioperative risks. However, catheter-based treatments require steep learning curves and are characterized by poor ergonomics and exposure to damaging radiation. ARTERY will offer a radiation-free approach based on shared-autonomy robotic catheters, with increased user engagement and easy interaction. Intraprocedural three-dimensional echocardiography as well as computed tomography images obtained during usual clinical practice will provide artificial intelligence algorithms that will turn catheter navigation to a simple task. Optical and electromagnetic sensing techniques will ensure a superior view upon the cardiovascular anatomy and will guide the autonomous catheter upon the interventionist supervision, who will be able to take over control at any instant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous cardiac procedures | – | Procedure: Percutaneous cardiac procedurePatients undergoing percutaneous cardiac procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidates to percutaneous cardiac defects repair
Key inclusion criteria (3 listed)
- adult patients
- patients admitted to hospital undergoing percutaneous cardiac procedure
- patients able to give informed consent
Key exclusion criteria (2 listed)
- age <18 years
- refuse to give informed consent
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 |
|---|---|---|
| Percutaneous cardiac procedureCollection and analysis of intraprocedural information to provide artificial intelligence algorithms | Procedure or surgery | Percutaneous cardiac procedures |
Primary outcome
Identification of key procedural elements that will benefit from the technological developments introduced by ARTERY by collecting intraprocedural images
Time frame: Intraoperative period
Number of patients undergoing percutaneous cardiac procedures
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 17 Aug 2025.
- Background: PubMed 39797996Munafo R, Saitta S, Tondi D, Ingallina G, Denti P, Maisano F, Agricola E, Votta E. Automatic 4D mitral valve segmentation from transesophageal echocardiography: a semi-supervised learning approach. Med Biol Eng Comput. 2025 Jan 11. doi: 10.1007/s11517-024-03275-w. Online ahead of print.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Disease and Heart Valve Diseases, run by Università Vita-Salute San Raffaele at 1 site in Italy.
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 3 inclusion and 2 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 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Identification of key procedural elements that will benefit from the technological developments introduced by ARTERY by collecting intraprocedural images (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04787757, which also lists 1 linked publication.
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 17 Aug 2025.