RECRUITING

ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Conditions

Aortic Valve Insufficiency Aortic Valve Stenosis Transcatheter aortic valve replacement (TAVR)Transcatheter aortic valve implantation (TAVI)SAPIEN X4 Valve-in-valve

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Official Title

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Quick Facts

Study Start:2023-11-22

Study Completion:2034-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05172973

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency 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.	1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system 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

Inclusion Criteria

Exclusion Criteria

1. Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
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.

1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
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

Contacts and Locations

Study Contact

Edwards THV Clinical Affairs

CONTACT

949-250-2500

THV_CT.gov@Edwards.com

Principal Investigator

Pradeep Yadav, MD

PRINCIPAL_INVESTIGATOR

Piedmont Atlanta Hospital

Robert Cubbedu, MD

PRINCIPAL_INVESTIGATOR

Naples Community Hospital

Study Locations (Sites)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

United States

Bay Area Structural Heart at Sutter Health

San Francisco, California, 94105

United States

Kaiser San Francisco

San Francisco, California, 94115

United States

Stanford University Medical Center

Stanford, California, 94305

United States

UC Health Medical Center of the Rockies

Loveland, Colorado, 80538

United States

Naples Community Hospital Healthcare System

Naples, Florida, 34102

United States

Emory University Atlanta

Atlanta, Georgia, 30308

United States

Piedmont Heart Institute

Atlanta, Georgia, 30309

United States

Northwestern University Chicago

Evanston, Illinois, 60208

United States

Alexian Brothers Hospital Network

Lisle, Illinois, 60532

United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226

United States

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Henry Ford Hospital Detroit

Detroit, Michigan, 48202

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Atlantic Health System Morristown

Morristown, New Jersey, 07960

United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901

United States

The Valley Hospital

Ridgewood, New Jersey, 07450

United States

Cornelll University New York

New York, New York, 10021

United States

Columbia University Medical Center / NYPH

New York, New York, 10032

United States

Rochester General Hospital

Rochester, New York, 14621

United States

Carolinas Health System

Charlotte, North Carolina, 28204

United States

Novant Health and Vascular Institute

Charlotte, North Carolina, 28204

United States

The Christ Hospital

Cincinnati, Ohio, 45219

United States

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

United States

Saint Thomas Health

Nashville, Tennessee, 37205

United States

University of Texas Memorial Hermann

Houston, Texas, 77030

United States

The Heart Hospital Baylor Plano

Plano, Texas, 75093

United States

University of Washington Seattle

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Edwards Lifesciences

Pradeep Yadav, MD, PRINCIPAL_INVESTIGATOR, Piedmont Atlanta Hospital
Robert Cubbedu, MD, PRINCIPAL_INVESTIGATOR, Naples Community Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-22

Study Completion Date2034-02

Study Record Updates

Study Start Date2023-11-22

Study Completion Date2034-02

Terms related to this study

Keywords Provided by Researchers

Transcatheter aortic valve replacement (TAVR)
Transcatheter aortic valve implantation (TAVI)
SAPIEN X4
Valve-in-valve

Additional Relevant MeSH Terms

Aortic Valve Insufficiency
Aortic Valve Stenosis