RecruitingNCT07075861
The ARTEMIS Data Collection Study
JenaValve Trilogy for Patients With Pure Native Aortic Valve Rigurgitation: the ARTEMIS Data Collection Study
Sponsor
IRCCS Policlinico S. Donato
Enrollment
75 participants
Start Date
Aug 10, 2025
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria4
- Considered at high or prohibitive risk for surgical aortic valve replacement by the Heart Team
- 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 Criteria1
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07075861
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