<?xml version="1.0" encoding="UTF-8"?><protocol_summary><protocol><id>13383</id><no>ALLIANCE-NCT05172960</no><status>Open</status><title>Safety and Effectiveness of Balloon-Expandable Bioprosthetic&#xD;
SAPIEN X4 Transcatheter Heart Valve</title><objective>The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).&#xD;
</objective><nct_id>NCT05172960</nct_id><sponsor_type>Industrial</sponsor_type><age_group>Adult</age_group><treatment_type>Treatment</treatment_type><treatment>Device: SAPIEN X4 THV&#xD;
</treatment><phase>N/A</phase><disease_site>Nonrheumatic aortic (valve) stenosis</disease_site><lay_description>Aortic Stenosis, Severe&#xD;
</lay_description><PI>Wang, John</PI><institution>MedStar Health and GUMC; Medstar Union Memorial Hospital</institution><management_group>MCRN - Baltimore Inpatient</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>