The ARTEMIS Data Collection Study
ConditionAortic Regurgitation Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Policlinico S. Donato
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
None
Trial design
Treatments tested in this trial
- Not listed
Trial groups
75 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov