Actively Recruiting
Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
Led by Edwards Lifesciences · Updated on 2025-12-22
200
Participants Needed
35
Research Sites
478 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in people who have a failing aortic bioprosthetic valve and are considered at high or greater risk for surgery. The study is a prospective, single-arm, multicenter trial focusing on this specific heart condition involving aortic valve insufficiency or stenosis. Participants will receive an implant of the SAPIEN X4 valve through a transcatheter aortic valve replacement (TAVR) procedure. There are two study groups: one for subjects with a failing surgical aortic valve and another for those with a failing transcatheter heart valve. The study involves implanting the balloon-expandable SAPIEN X4 valve to replace the failing bioprosthetic valve. During the study, participants will be closely monitored with assessments including the occurrence of death and stroke over one year, and measures of heart function and quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and New York Heart Association (NYHA) functional class at 30 days and one year. The study involves no randomization or masking, and participants will be followed to assess the valve's performance and safety throughout the study duration.
CONDITIONS
Brief Title
ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Failing aortic bioprosthetic valve demonstrating moderate or greater stenosis and/or insufficiency
- Bioprosthetic valve size suitable for SAPIEN X4 THV
- New York Heart Association (NYHA) functional class II or higher
- Heart team agrees subject is at high or greater surgical risk
- Subject has been informed about the study and provided written consent
You will not qualify if you...
- Anatomical features preventing safe femoral access or delivery system passage
- Moderate or severe paravalvular regurgitation on failing valve
- Failing valve is unstable, rocking, or structurally damaged
- Severe patient-prosthesis mismatch or residual mean gradient over 20 mmHg after original valve implantation
- Increased risk of valve embolization
- Presence of surgical or transcatheter valve in mitral position
- Severe mitral regurgitation (greater than 3+) or moderate or worse mitral stenosis
- Need for mitral, tricuspid, or pulmonic valve intervention within 12 months
- Left ventricular ejection fraction below 20%
- Intracardiac mass, thrombus, or vegetation seen on imaging
- Increased risk of coronary artery obstruction after valve implantation
- Recent myocardial infarction within 30 days prior to procedure
- Hypertrophic cardiomyopathy with subvalvular obstruction
- Planned ablation for atrial fibrillation
- Significant coronary artery disease requiring revascularization
- Any surgical or transcatheter procedure within 30 days prior (excluding pacemaker or defibrillator implantation)
- Planned surgical or transcatheter intervention within 30 days after procedure
- Endocarditis within 180 days prior to procedure
- Stroke, transient ischemic attack, or neurological symptoms related to carotid or vertebrobasilar disease within 90 days
- Hemodynamic or respiratory instability needing inotropic or mechanical support within 30 days
- Renal insufficiency or needing renal replacement therapy
- Leukopenia, anemia, or thrombocytopenia
- Unable to tolerate or contraindicated for antithrombotic therapy
- Hypercoagulable state or increased thrombosis risk
- Allergy to iodinated contrast that cannot be pretreated
- Refusal of blood products
- Body mass index over 50 kg/m2
- Life expectancy less than 24 months
- Female who is pregnant or breastfeeding
- Active COVID-19 infection or recent COVID-19 with lasting effects
- Participation in another investigational drug or device study not completed
- Considered part of a vulnerable population
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive the implantation of the SAPIEN X4 transcatheter heart valve for failing aortic bioprosthetic valves.
1 implantation visit (in-person)
Duration - Up to 1 year
Participants are monitored for safety and effectiveness of the implanted valve, including assessments of heart function and symptoms.
Visits at 30 days and 1 year post-implantation
Trial Site Locations
Total: 35 locations
1
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
2
Bay Area Structural Heart at Sutter Health
San Francisco, California, United States, 94105
Actively Recruiting
3
Kaiser San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
4
Stanford University Medical Center
Stanford, California, United States, 94305
Actively Recruiting
5
UC Health Medical Center of the Rockies
Loveland, Colorado, United States, 80538
Actively Recruiting
6
Naples Community Hospital Healthcare System
Naples, Florida, United States, 34102
Actively Recruiting
7
Emory University Atlanta
Atlanta, Georgia, United States, 30308
Actively Recruiting
8
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
9
Northwestern University Chicago
Evanston, Illinois, United States, 60208
Actively Recruiting
10
Alexian Brothers Hospital Network
Lisle, Illinois, United States, 60532
Actively Recruiting
11
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States, 67226
Actively Recruiting
12
MedStar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
Actively Recruiting
13
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
14
Henry Ford Hospital Detroit
Detroit, Michigan, United States, 48202
Actively Recruiting
15
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
16
Atlantic Health System Morristown
Morristown, New Jersey, United States, 07960
Actively Recruiting
17
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
18
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Actively Recruiting
19
University of Buffalo
Buffalo, New York, United States, 14203
Actively Recruiting
20
Cornelll University New York
New York, New York, United States, 10021
Actively Recruiting
21
Columbia University Medical Center / NYPH
New York, New York, United States, 10032
Actively Recruiting
22
Rochester General Hospital
Rochester, New York, United States, 14621
Actively Recruiting
23
Carolinas Health System
Charlotte, North Carolina, United States, 28204
Actively Recruiting
24
Novant Health and Vascular Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
25
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
26
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
27
Oklahoma Heart Institute
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
28
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
29
Saint Thomas Health
Nashville, Tennessee, United States, 37205
Actively Recruiting
30
University of Texas Memorial Hermann
Houston, Texas, United States, 77030
Actively Recruiting
31
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Actively Recruiting
32
University of Washington Seattle
Seattle, Washington, United States, 98195
Withdrawn
33
St. Paul's Hospital Vancouver
Vancouver, British Columbia, Canada, V6Z1Y6
Actively Recruiting
34
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
35
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval
Québec, Canada, G1V4G5
Actively Recruiting
Research Team
E
Edwards THV Clinical Affairs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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