Evaluation of the Navitor Transcatheter Heart Valve in Low and Intermediate Surgical Risk Patients who have Severe Symptomatic Aortic Stenosis Requiring Aortic Valve Replacement

Brief description of study

The ENVISION Clinical Trial is studying the Navitor™ Transcatheter Aortic Valve Implantation (TAVI) System in patients with severe, symptomatic aortic stenosis who are deemed low or intermediate surgical risk.

Approximately 1,500 patients will be studied at up to 95 centers globally. A select team of physicians will monitor the patients included in the ENVISION Clinical Trial.

Clinical trial participants will play an important role in helping physicians evaluate the use of the Navitor TAVI System for patients with severe aortic stenosis.

Clinical Study Identifier: s24-00333

ClinicalTrials.gov Identifier: NCT05932615

Principal Investigator: Mathew R. Williams.

Other Investigators: Alan F Vainrib, Muhamed Saric, Cezar S Staniloae.

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