Ireland
--:--IST
Recruiting Observational

The ARTEMIS Data Collection Study

NCT07075861 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-08-10
Last updated
2025-12-24

Condition(s) studied

Aortic Regurgitation Disease

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Device success at 12 months — 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)

Trial sites (1)

FacilityCityRegionStatus
IRCCS Policlinico San Donato San Donato Milanese Milano Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07075861 on ClinicalTrials.gov ↗ ← All trials in Italy