ClinicalTrials.gov record
ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
ClinicalTrials.gov ID: NCT05172960
Public ClinicalTrials.gov record NCT05172960. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).
Study identification
- NCT ID
- NCT05172960
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,234 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 19, 2022
- Primary completion
- Jun 30, 2027
- Completion
- Dec 31, 2036
- Last update posted
- Sep 2, 2026
2022 – 2037
United States locations
- U.S. sites
- 58
- U.S. states
- 26
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scripps Memorial Hospital La Jolla | La Jolla | California | 92037 | Active, not recruiting |
| Kaiser Los Angeles | Los Angeles | California | 90027 | Active, not recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Recruiting |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | Active, not recruiting |
| UC Davis Medical Center Sacramento | Sacramento | California | 95817 | Active, not recruiting |
| Bay Area Structural Heart at Sutter Health | San Francisco | California | 94109 | Recruiting |
| Kaiser San Francisco Medical Center | San Francisco | California | 94115 | Active, not recruiting |
| Stanford University | Stanford | California | 94305 | Active, not recruiting |
| UC Health Northern Colorado (Medical Center of the Rockies) | Loveland | Colorado | 80538 | Active, not recruiting |
| Hartford Hospital | Hartford | Connecticut | 06102 | Active, not recruiting |
| Naples Community Hospital Healthcare System | North Naples | Florida | 34102 | Active, not recruiting |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | Active, not recruiting |
| Emory University Atlanta | Atlanta | Georgia | 30322 | Active, not recruiting |
| Rush University Medical Center Chicago | Chicago | Illinois | 60612 | Active, not recruiting |
| Alexian Brothers Hospital Network | Elk Grove Village | Illinois | 60007 | Recruiting |
| NorthShore University HealthSystem Research Institute Evanston | Evanston | Illinois | 60201 | Recruiting |
| Northwestern University Chicago | Evanston | Illinois | 60611 | Recruiting |
| Silver Cross Hospital | New Lenox | Illinois | 60541 | Recruiting |
| St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC | Carmel | Indiana | 46290 | Active, not recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Active, not recruiting |
| Ascension Via Christi St. Francis (Cardiovascular Research Institute of Kansas) | Wichita | Kansas | 67226 | Recruiting |
| Medstar Union Memorial Hospital | Baltimore | Maryland | 21218 | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Recruiting |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Active, not recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | Active, not recruiting |
| CentraCare Heart and Vascular Center | Saint Cloud | Minnesota | 56303 | Active, not recruiting |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | Active, not recruiting |
| Washington University - Barnes-Jewish Hospital Saint Louis | St Louis | Missouri | 63110 | Recruiting |
| St. Patrick Hospital | Missoula | Montana | 59802 | Active, not recruiting |
| Dartmouth-Hitchcock Medical Center, Hanover | Lebanon | New Hampshire | 03756 | Recruiting |
| Atlantic Health System Morristown | Morristown | New Jersey | 07960 | Recruiting |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | Recruiting |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | Active, not recruiting |
| University at Buffalo - Kaleida Health | Buffalo | New York | 14203 | Recruiting |
| Cornell Medical Center | New York | New York | 10021 | Recruiting |
| Columbia University Medical Center/NYPH | New York | New York | 10032 | Recruiting |
| Montefiore Medical Center | New York | New York | 10458 | Active, not recruiting |
| Carolinas Health System | Charlotte | North Carolina | 28203 | Active, not recruiting |
| Novant Health and Heart Vascular Institute | Charlotte | North Carolina | 28204 | Recruiting |
| The Christ Hospital | Cincinnati | Ohio | 45219 | Recruiting |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | Active, not recruiting |
| Oklahoma Cardiovascular Research Group Oklahoma City | Oklahoma City | Oklahoma | 73120 | Recruiting |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74104 | Recruiting |
| Kaiser Portland | Clackamas | Oregon | 97015 | Recruiting |
| Providence Heart & Vascular Institute Portland | Portland | Oregon | 97225 | Active, not recruiting |
| Pinnacle Health Harrisburg | Harrisburg | Pennsylvania | 17101 | Completed |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | Active, not recruiting |
| Methodist Le Bonheur Healthcare | Germantown | Tennessee | 38138 | Active, not recruiting |
| Centennial Medical Center | Nashville | Tennessee | 37203 | Recruiting |
| Saint Thomas Health | Nashville | Tennessee | 37205 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | Recruiting |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | Active, not recruiting |
| HCA Houston Healthcare Medical Center | Houston | Texas | 77004 | Active, not recruiting |
| University of Texas Memorial Hermann | Houston | Texas | 77030 | Active, not recruiting |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | Recruiting |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | Active, not recruiting |
| University of Washington Seattle | Seattle | Washington | 98195 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05172960, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05172960 live on ClinicalTrials.gov.