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โ† Trials
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The ARTEMIS Data Collection Study

Recruitingn/aAges 18 Years - anyAllIRCCS Policlinico S. Donato
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In plain words

What the trial is, and whether it could suit you

To observe the safety and effectiveness of the JenaValve Trilogyโ„ข Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with evere native aortic regurgitation (AR) who are indicated for TAVR Data collection

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
IRCCS Policlinico San Donato
San Donato Milanese, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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