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ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
NCT05172960 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DEVICE SAPIEN X4 THV
Study Locations (20)
California
- Scripps Memorial Hospital La Jolla — La Jolla
- Kaiser Los Angeles — Los Angeles
- Cedars-Sinai Medical Center — Los Angeles
- Hoag Memorial Hospital Presbyterian — Newport Beach
- UC Davis Medical Center Sacramento — Sacramento
- Bay Area Structural Heart at Sutter Health — San Francisco
- Kaiser San Francisco Medical Center — San Francisco
- Stanford University — Stanford
Illinois
- Rush University Medical Center Chicago — Chicago
- Alexian Brothers Hospital Network — Elk Grove Village
- NorthShore University HealthSystem Research Institute Evanston — Evanston
- Northwestern University Chicago — Evanston
- Silver Cross Hospital — New Lenox
Georgia
- Piedmont Heart Institute — Atlanta
- Emory University Atlanta — Atlanta
Colorado
- UC Health Northern Colorado (Medical Center of the Rockies) — Loveland
Connecticut
- Hartford Hospital — Hartford
Florida
- Naples Community Hospital Healthcare System — North Naples
Indiana
- St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC — Carmel
Kansas
- University of Kansas Medical Center — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 915 participants |
| Start Date | 2022-06-20 |
| Est. Completion | 2034-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05172960
The ClinicalTrials.gov registry entry for NCT05172960 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 915 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Aortic Stenosis, Severe appearing as the primary indexed condition, and to 1 intervention — of which SAPIEN X4 THV is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05172960 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Illinois, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05172960 about?
NCT05172960 is a clinical study titled "ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve". 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).
What is the current status of trial NCT05172960?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 915 participants. The study started on 2022-06-20. Estimated completion is 2034-12.
What conditions does trial NCT05172960 study?
This clinical trial studies the following conditions: Aortic Stenosis, Severe. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05172960?
The interventions under investigation include: SAPIEN X4 THV (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05172960?
This trial is sponsored by Edwards Lifesciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05172960 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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