ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
NCT ID: NCT05172973
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-11-22
2036-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transcatheter Aortic Valve Replacement (TAVR) - Surgical Valve
TAVR implant in subjects with a failing aortic surgical valve.
SAPIEN X4 THV
Implantation of the SAPIEN X4 valve
Transcatheter Aortic Valve Replacement (TAVR) - THV
TAVR implant in subjects with a failing aortic transcatheter heart valve (THV).
SAPIEN X4 THV
Implantation of the SAPIEN X4 valve
Interventions
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SAPIEN X4 THV
Implantation of the SAPIEN X4 valve
Eligibility Criteria
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Inclusion Criteria
2. Bioprosthetic valve size suitable for SAPIEN X4 THV
3. NYHA functional class ≥ II
4. Heart Team agrees the subject is at high or greater surgical risk
5. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria
2. Failing valve has moderate or severe paravalvular regurgitation
3. Failing valve is unstable, rocking, or not structurally intact
4. Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve
5. Increased risk of THV embolization
6. Surgical or transcatheter valve in the mitral position
7. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis
8. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months
9. Left ventricular ejection fraction \< 20%
10. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
11. Increased risk of coronary artery obstruction after THV implantation
12. Myocardial infarction within 30 days prior to the study procedure
13. Hypertrophic cardiomyopathy with subvalvular obstruction
14. Subjects with planned concomitant ablation for atrial fibrillation
15. Clinically significant coronary artery disease requiring revascularization
16. Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
17. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
18. Endocarditis within 180 days prior to the study procedure
19. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
20. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
21. Renal insufficiency and/or renal replacement therapy
22. Leukopenia, anemia, thrombocytopenia
23. Inability to tolerate or condition precluding treatment with antithrombotic therapy
24. Hypercoagulable state or other condition that increases risk of thrombosis
25. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
26. Subject refuses blood products
27. Body mass index \> 50 kg/m2
28. Estimated life expectancy \< 24 months
29. Female who is pregnant or lactating
30. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
31. Participating in another investigational drug or device study that has not reached its primary endpoint
32. Subject considered to be part of a vulnerable population
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Pradeep Yadav, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Atlanta Hospital
Robert Cubbedu, MD
Role: PRINCIPAL_INVESTIGATOR
Naples Community Hospital
Locations
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Bay Area Structural Heart at Sutter Health
San Francisco, California, United States
Kaiser San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
UC Health Medical Center of the Rockies
Loveland, Colorado, United States
Naples Community Hospital Healthcare System
Naples, Florida, United States
Emory University Atlanta
Atlanta, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northwestern University Chicago
Evanston, Illinois, United States
Alexian Brothers Hospital Network
Lisle, Illinois, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States
MedStar Union Memorial Hospital
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Hospital Detroit
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Atlantic Health System Morristown
Morristown, New Jersey, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States
The Valley Hospital
Ridgewood, New Jersey, United States
University of Buffalo
Buffalo, New York, United States
Cornelll University New York
New York, New York, United States
Columbia University Medical Center / NYPH
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Carolinas Health System
Charlotte, North Carolina, United States
Novant Health and Vascular Institute
Charlotte, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Saint Thomas Health
Nashville, Tennessee, United States
University of Texas Memorial Hermann
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
University of Washington Seattle
Seattle, Washington, United States
St. Paul's Hospital Vancouver
Vancouver, British Columbia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval
Québec, , Canada
Countries
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Central Contacts
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Other Identifiers
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2021-05-AVIV
Identifier Type: -
Identifier Source: org_study_id