TRISCEND II Pivotal Trial

Brief description of study

The goal of this trial is to evaluate the safety and effectiveness of the Edwards EVOQUE System with Optimal Medical Therapy (OMT) compared to OMT alone in the treatment of patients with severe tricuspid regurgitation. Tricuspid regurgitation is a condition in which your heart’s tricuspid valve does not close tightly which causes blood to flow backwards in the wrong direction during part of the cardiac cycle (heart beat). This condition increases the workload on the heart and, if left untreated, it can increase the risk of worsening heart failure. The standard medical treatments generally available to patients with tricuspid regurgitation who do not undergo surgery may temporarily alleviate some of your symptoms but will not permanently alleviate your condition or cure your tricuspid regurgitation. The EVOQUE System is an investigational (experimental) device. This means the EVOQUE System is not approved by the U.S. Food and Drug Administration (FDA) to treat severe tricuspid regurgitation, and that there are limited data about its safety and effectiveness in the treatment of tricuspid regurgitation


Clinical Study Identifier: s20-01862
ClinicalTrials.gov Identifier: NCT04482062
Principal Investigator: Mathew R. Williams.
Other Investigators: Tara Ann Collins, Alan F Vainrib, Muhamed Saric, Daniel G Bamira, Alex Reyentovich, Cezar S Staniloae, Bernard Shown Kadosh.


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