The ARTEMIS Data Collection Study

Recruiting now

Conditions studied: Aortic Regurgitation Disease

In brief

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

Key facts

Study ID

NCT07075861

Run by

IRCCS Policlinico S. Donato

People needed

75

Starts

2025-08-10

Expected to finish

2028-08-10

Last updated by the study team

2025-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

• IRCCS Policlinico San Donato — San Donato Milanese, Milano, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.