Aortic Regurgitation DiseaseARTEMISNCT07075861
The ARTEMIS Data Collection Study
An observational study of Aortic Regurgitation Disease, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
To observe the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data collection Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Regurgitation Disease
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 10 Aug 2025to 10 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient with severe symptomatic aortic valve regurgitation in a native valve. According to the local experience in TAVR, the number of patients with severe AR deemed at prohibitive surgical risk is around 2/month. Considering a prospective enrollment of 2 years and historical patients collected data for 1 year, the final number of expected patients will be about 75. In fact, according to reference [1], a composite of all-cause mortality and heart failure ehospitalization at 1 year had cumulative incidence of about 17%. Therefore, considering an exponential distribution with event rate 0.17 (17 events per 100 person years), 75 patients amount to a total of 75-13*.5=68 person years. The resulting 95% confidence interval of the cumulative incidence will be 0.06; 0.24 [2].
Who may be able to join
- Considered at high or prohibitive risk for surgical aortic valve replacement by the Heart Team
- 18 years of age or older
- Suitable anatomy according to the IFU
- Absence of significant disease of the ascending aorta, including ascending aortic aneurysm (defined as maximal luminal diameter of 50mm or greater) or atheroma (especially if thick [>5mm], protruding or ulcerated)
Who cannot join
- The JenaValve Trilogy Heart Valve System is contraindicated for use in patients who have known hypersensitivity or contraindication to Nitinol (titanium and/or nickel), an anti-coagulation/anti-platelet regimen or contrast medium that cannot be managed with premedication, or who have active bacterial endocarditis or other active infections.
- The JenaValve Trilogy Heart Valve System is contraindicated in those patients whose anatomy does not accommodate the System due to anatomical considerations outlined in the inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Milano, 20097
Federica Rossi, Study Coordinator, 0252774984 ext. 0039, federica.rossi@grupposandonato.it
Mattia Ricotti, 0252774236 ext. 0039, mattia.ricotti@grupposandonato.it
About this study
Official title: JenaValve Trilogy for Patients With Pure Native Aortic Valve Rigurgitation: the ARTEMIS Data Collection Study
To observe the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data collection
Read the detailed description
To observe the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data collection .
A retrospective/prospective, single-arm, post-market study to monitor the outcomes of Jena Valve Trilogy in a real-world clinical setting .
After enrollment is completed, patients are followed to 1 year (an amendment to extend the follow up to 5 years will be evaluated). Thereafter, the patient exits the data collection study and is to be followed per institutional standard of care for TAVR patients.
The JenaValve Trilogy™ Heart Valve System contains the following sub-components: a prosthetic transcatheter porcine pericardial aortic valve, 20Fr Introducer Sheath System, transfemoral Delivery Catheter, and Loading Tool.
Indications for Use: The JenaValve Trilogy™ Heart Valve System is indicated for use in patients with clinically significant aortic regurgitation (AR) who are considered high risk candidates for surgical aortic valve replacement as deemed by the local multi-disciplinary heart team.
This is an investigator initiated study that will include 75 suitable patients according to the inclusion/exclusion criteria as per IFU.
- Conditions
- Aortic Regurgitation Disease
- Keywords
- JenaValve Trilogy, Aortic Regurgitation, TAVI
- Medical subject headings
- Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with symptomatic, severe, native aortic regurgitation | patients with symptomatic, severe, native aortic regurgitation retrospectively or prospectively treated with TAVI JenaValve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device success at 12 months
Freedom from all-cause mortality
- Freedom from unsuccessful delivery of the device, and retrieval of the delivery system
- Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location
- Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication
- Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start10 Aug 2025
- Primary completion10 Aug 2028 (estimated)
- Study completion10 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Regurgitation 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
- Other
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luca Testa, PI, Principal investigator, IRCCS Policlinico San Donato (San Donato Milanese) - IT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075861
- Sponsor's protocol ID
- CET 203-2025
- Acronym
- ARTEMIS
- Status last verified
- Nov 2025
- First submitted
- 10 Jul 2025
- Last updated
- 24 Dec 2025
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JenaValve Trilogy for Patients With Pure Native Aortic Valve Rigurgitation: the ARTEMIS Data Collection Study
- ClinicalTrials.gov ID
- NCT07075861
- Acronym / sponsor ID
- ARTEMIS / CET 203-2025
- Conditions
- Aortic Regurgitation Disease
- Keywords
- JenaValve Trilogy, Aortic Regurgitation, TAVI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 10 Aug 2028 (estimated)
- Study completion
- 10 Aug 2028 (estimated)
- First posted
- 20 Jul 2025 (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.
To observe the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data collection
Detailed description
To observe the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data collection .
A retrospective/prospective, single-arm, post-market study to monitor the outcomes of Jena Valve Trilogy in a real-world clinical setting .
After enrollment is completed, patients are followed to 1 year (an amendment to extend the follow up to 5 years will be evaluated). Thereafter, the patient exits the data collection study and is to be followed per institutional standard of care for TAVR patients.
The JenaValve Trilogy™ Heart Valve System contains the following sub-components: a prosthetic transcatheter porcine pericardial aortic valve, 20Fr Introducer Sheath System, transfemoral Delivery Catheter, and Loading Tool.
Indications for Use: The JenaValve Trilogy™ Heart Valve System is indicated for use in patients with clinically significant aortic regurgitation (AR) who are considered high risk candidates for surgical aortic valve replacement as deemed by the local multi-disciplinary heart team.
This is an investigator initiated study that will include 75 suitable patients according to the inclusion/exclusion criteria as per IFU.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with symptomatic, severe, native aortic regurgitation | – | –patients with symptomatic, severe, native aortic regurgitation retrospectively or prospectively treated with TAVI JenaValve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with severe symptomatic aortic valve regurgitation in a native valve. According to the local experience in TAVR, the number of patients with severe AR deemed at prohibitive surgical risk is around 2/month. Considering a prospective enrollment of 2 years and historical patients collected data for 1 year, the final number of expected patients will be about 75. In fact, according to reference [1], a composite of all-cause mortality and heart failure ehospitalization at 1 year had cumulative incidence of about 17%. Therefore, considering an exponential distribution with event rate 0.17 (17 events per 100 person years), 75 patients amount to a total of 75-13*.5=68 person years. The resulting 95% confidence interval of the cumulative incidence will be 0.06; 0.24 [2].
Key inclusion criteria (4 listed)
- Considered at high or prohibitive risk for surgical aortic valve replacement by the Heart Team
Key exclusion criteria (2 listed)
- The JenaValve Trilogy Heart Valve System is contraindicated for use in patients who have known hypersensitivity or contraindication to Nitinol (titanium and/or nickel), an anti-coagulation/anti-platelet regimen or contrast medium that cannot be managed with premedication, or who have active bacterial endocarditis or other active infections.
- The JenaValve Trilogy Heart Valve System is contraindicated in those patients whose anatomy does not accommodate the System due to anatomical considerations outlined in the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Device success at 12 months
Time frame: 12 months
Freedom from all-cause mortality * Freedom from unsuccessful delivery of the device, and retrieval of the delivery system * Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
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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.
Luca Testa, PI principal investigator
IRCCS Policlinico San Donato (San Donato Milanese) - IT
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 Aortic Regurgitation Disease, run by IRCCS Policlinico S. Donato 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 4 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: looking for participants now, as of the sponsor's last update on 24 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federica Rossi, Study Coordinator (0252774984 ext. 0039, federica.rossi@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device success at 12 months (time frame: 12 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 24 Dec 2025.