NCT05172960From ClinicalTrials.govRecruiting

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve

Aortic Stenosis, Severe

At a glance

Phase: Phase not stated
Study type: Interventional
Sponsor: Edwards Lifesciences
Enrolment target: 1,234
Started: 20 June 2022
Main results due: July 2027
Study sites: 65
Registry updated: 24 September 2026

Can you take part?

No age limit is stated.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

1. Severe, calcific AS
2. Native aortic annulus size suitable for SAPIEN X4 THV
3. NYHA functional class ≥ II
4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
2. Aortic valve is unicuspid, bicuspid or non-calcified
3. Pre-existing mechanical or bioprosthetic valve in any position
4. Severe aortic regurgitation (\> 3+)
5. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
6. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
7. Left ventricular ejection fraction \< 20%
8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation
10. Increased risk of coronary artery obstruction after THV implantation
11. Myocardial infarction within 30 days prior to the study procedure
12. Hypertrophic cardiomyopathy with subvalvular obstruction
13. Subjects with planned concomitant ablation for atrial fibrillation
14. Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
15. Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
16. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD)
17. Endocarditis within 180 days prior to the study procedure
18. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
19. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
20. Renal insufficiency and/or renal replacement therapy
21. Leukopenia, anemia, thrombocytopenia
22. Inability to tolerate or condition precluding treatment with antithrombotic therapy
23. Hypercoagulable state or other condition that increases risk of thrombosis
24. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
25. Subject refuses blood products
26. BMI \> 50 kg/m2
27. Estimated life expectancy \< 24 months
28. Female who is pregnant or lactating
29. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
30. Participating in another investigational drug or device study that has not reached its primary endpoint
31. Subject considered to be part of a vulnerable population

What this study is about

In the sponsor’s own words, from the registry.

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 sites(65)

Scripps Memorial Hospital La Jolla
La Jolla, California, United States
Active, not recruiting
Kaiser Los Angeles
Los Angeles, California, United States
Active, not recruiting
Cedars-Sinai Medical Center
Los Angeles, California, United States
Recruiting
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Active, not recruiting
UC Davis Medical Center Sacramento
Sacramento, California, United States
Recruiting
Bay Area Structural Heart at Sutter Health
San Francisco, California, United States
Recruiting
Kaiser San Francisco Medical Center
San Francisco, California, United States
Active, not recruiting
Stanford University
Stanford, California, United States
Recruiting
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland, Colorado, United States
Active, not recruiting
Hartford Hospital
Hartford, Connecticut, United States
Recruiting
Naples Community Hospital Healthcare System
North Naples, Florida, United States
Active, not recruiting
Piedmont Heart Institute
Atlanta, Georgia, United States
Active, not recruiting
Emory University Atlanta
Atlanta, Georgia, United States
Active, not recruiting
Rush University Medical Center Chicago
Chicago, Illinois, United States
Active, not recruiting
Alexian Brothers Hospital Network
Elk Grove Village, Illinois, United States
Recruiting
NorthShore University HealthSystem Research Institute Evanston
Evanston, Illinois, United States
Recruiting
Northwestern University Chicago
Evanston, Illinois, United States
Recruiting
Silver Cross Hospital
New Lenox, Illinois, United States
Recruiting
St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC
Carmel, Indiana, United States
Active, not recruiting
University of Kansas Medical Center
Kansas City, Kansas, United States
Active, not recruiting
Ascension Via Christi St. Francis (Cardiovascular Research Institute of Kansas)
Wichita, Kansas, United States
Recruiting
Medstar Union Memorial Hospital
Baltimore, Maryland, United States
Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, United States
Recruiting
Henry Ford Hospital
Detroit, Michigan, United States
Active, not recruiting
Mayo Clinic Rochester
Rochester, Minnesota, United States
Active, not recruiting
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States
Active, not recruiting
Saint Luke's Hospital
Kansas City, Missouri, United States
Active, not recruiting
Washington University - Barnes-Jewish Hospital Saint Louis
St Louis, Missouri, United States
Recruiting
St. Patrick Hospital
Missoula, Montana, United States
Active, not recruiting
Dartmouth-Hitchcock Medical Center, Hanover
Lebanon, New Hampshire, United States
Recruiting
Atlantic Health System Morristown
Morristown, New Jersey, United States
Recruiting
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Recruiting
The Valley Hospital
Ridgewood, New Jersey, United States
Active, not recruiting
University at Buffalo - Kaleida Health
Buffalo, New York, United States
Recruiting
Cornell Medical Center
New York, New York, United States
Recruiting
Columbia University Medical Center/NYPH
New York, New York, United States
Recruiting
Montefiore Medical Center
New York, New York, United States
Active, not recruiting
Carolinas Health System
Charlotte, North Carolina, United States
Active, not recruiting
Novant Health and Heart Vascular Institute
Charlotte, North Carolina, United States
Recruiting
The Christ Hospital
Cincinnati, Ohio, United States
Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Active, not recruiting
Oklahoma Cardiovascular Research Group Oklahoma City
Oklahoma City, Oklahoma, United States
Recruiting
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Recruiting
Kaiser Portland
Clackamas, Oregon, United States
Recruiting
Providence Heart & Vascular Institute Portland
Portland, Oregon, United States
Active, not recruiting
Pinnacle Health Harrisburg
Harrisburg, Pennsylvania, United States
Completed
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Recruiting
Methodist Le Bonheur Healthcare
Germantown, Tennessee, United States
Active, not recruiting
Centennial Medical Center
Nashville, Tennessee, United States
Recruiting
Saint Thomas Health
Nashville, Tennessee, United States
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Recruiting
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
Recruiting
Medical City Dallas Hospital
Dallas, Texas, United States
Active, not recruiting
HCA Houston Healthcare Medical Center
Houston, Texas, United States
Active, not recruiting
University of Texas Memorial Hermann
Houston, Texas, United States
Active, not recruiting
The Heart Hospital Baylor Plano
Plano, Texas, United States
Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Recruiting
University of Washington Seattle
Seattle, Washington, United States
Active, not recruiting
St. Andrews War Memorial Hospital
Spring Hill, Queensland, Australia
Active, not recruiting
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Active, not recruiting

Showing 60 of 65 sites — filter to narrow it down. 31 of the 65 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05172960. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me