The ARTEMIS Data Collection 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.

Conditions2

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