<?xml version="1.0" encoding="UTF-8"?><protocol_summary><protocol><id>10103</id><no>CORMATRIX-NCT02397668</no><status>Open</status><title>CORMATRIX® COR&#x99; TRICUSPID ECM® VALVE REPLACEMENT SAFETY AND EARLY FEASIBILITY STUDY</title><objective>To demonstrate the proof of principle and initial clinical safety of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve) and increase the efficiency of the device development process by identifying appropriate modifications to the implant procedure or the device.</objective><nct_id>NCT02397668</nct_id><sponsor_type>Industrial</sponsor_type><age_group>Adult</age_group><treatment_type>Treatment</treatment_type><treatment>Device: CorMatrix Cor TRICUSPID ECM Valve&#xD;
</treatment><phase>II</phase><disease_site>Diseases Of The Circulatory System</disease_site><lay_description>Tricuspid Valve Disease</lay_description><PI>Bethea, Brian</PI><institution>MedStar Health and GUMC; Medstar Union Memorial Hospital</institution><management_group>MCRN - Baltimore Inpatient; MCRN - Cardiac Surgery</management_group></protocol><sipVersion>2026.1.0 Build 16</sipVersion><copyright> &lt;a href="https://advarra.com" target="_blank"&gt;&amp;copy; 2026 Advarra, Inc.&lt;/a&gt; </copyright></protocol_summary>