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First received: January 30, 2023

Clinical Trial: CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study

Study Status: Completed

Recruit Status: RECRUITING

Condition: Tricuspid Valve Disease

Study Type: INTERVENTIONAL


Official Title: CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study

Brief Summary: The goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM (extracellular matrix) Valve (or Cor PEDIATRIC Tricuspid ECM Valve) for the surgical management of tricuspid valve disease and dysfunction in adult and pediatric patients.The main question(s) it aims to answer are:whether the device may be implanted successfully and safely, andwhether the device effectively treats tricuspid valve disease and dysfunction through 12 monthsParticipants will undergo:preoperative…

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