ARTEMIS: JenaValve Trilogy data collection for severe aortic regurgitation
JenaValve Trilogy for Patients With Pure Native Aortic Valve Rigurgitation: the ARTEMIS Data Collection Study
This project will try the JenaValve Trilogy transcatheter heart valve in adults with severe native aortic regurgitation who are high or prohibitive risk for open-heart surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, Milano) |
| Trial ID | NCT07075861 on ClinicalTrials.gov |
What this trial studies
ARTEMIS is a single-arm, retrospective/prospective post-market data collection that follows up to 75 patients treated with the JenaValve Trilogy system for severe native aortic regurgitation. The study captures real-world safety and effectiveness outcomes after TAVR using the Trilogy valve, with planned follow-up to one year (an extension to five years may be added). Enrollment is at IRCCS Policlinico San Donato and includes patients selected by the local heart team who meet the device instructions for use. Data collected will include procedural details, complications, and clinical outcomes reported under routine clinical care.
Who should consider this trial
Good fit: Adults (≥18 years) with severe native aortic regurgitation who are deemed high or prohibitive surgical risk by the local heart team and who have anatomy suitable for the JenaValve Trilogy per the instructions for use.
Not a fit: Patients with known hypersensitivity to nitinol or device materials, active bacterial endocarditis or other active infections, inability to tolerate required anticoagulation/antiplatelet therapy or contrast, or anatomy incompatible with the device are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, this could offer a less invasive valve replacement option for patients with severe aortic regurgitation who are poor candidates for surgical replacement.
How similar studies have performed: Previous single-arm registries and small series of transcatheter valves for aortic regurgitation, including prior JenaValve reports, have shown feasibility and reasonable outcomes in selected patients but randomized comparative evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: 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.
Where this trial is running
San Donato Milanese, Milano
- IRCCS Policlinico San Donato — San Donato Milanese, Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Testa, PI — IRCCS Policlinico San Donato (San Donato Milanese) - IT
- Study coordinator: Federica Rossi, Study Coordinator
- Email: federica.rossi@grupposandonato.it
- Phone: 0252774984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.