Clinical Trials in Italy / NCT07075861
Recruiting
Observational
The ARTEMIS Data Collection Study
NCT07075861 · tracked via the Priya Life Science Italy tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCCS Policlinico San Donato | San Donato Milanese | Milano | Recruiting |
More IRCCS Policlinico S. Donato trials in Italy
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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