What this study is
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
What's being tested
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Intervention · DEVICE
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.
Study details
- Official title
- A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
- Sponsor
- Edwards Lifesciences
- Conditions
- Aortic Stenosis · Aortic Stenosis, Severe
- Enrolling
- 125 people
- Starts
- 2017-01-05
- Est. completion
- 2038-04
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
- Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
- NYHA Functional Class ≥ II.
- Heart Team agrees the patient is low to intermediate risk.
- Heart Team agrees valve implantation will likely benefit the patient.
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
You can't join if
- Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
- Severe regurgitation (> 3+) or stenosis of any other valve
- Failing valve has moderate or severe paravalvular regurgitation
- Failing valve is unstable, rocking, or not structurally intact
- Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
- Increased risk of embolization of THV
- Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
- Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
- Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
- Anatomical characteristics that would preclude safe access to the apex (Transapical)
- Evidence of an acute myocardial infarction ≤ 30 days before enrollment
- Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
- Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
- Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
- Untreated clinically significant coronary artery disease requiring revascularization
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
- Emergency interventional/surgical procedures within 30 days prior to the procedure
- Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure
- Hypertrophic cardiomyopathy with obstruction
- LVEF < 30%
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
- Stroke or transient ischemic attack within 90 days of enrollment
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
- Renal insufficiency and/or renal replacement therapy at the time of screening
- Active bacterial endocarditis within 180 days of the procedure
- Patient refuses blood products
- Estimated life expectancy < 24 months
- Positive urine or serum pregnancy test in female subjects of childbearing potential
- Currently participating in an investigational drug or another device study
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (51)
30 openBanner University Medical Center
Phoenix, Arizona, United States
RecruitingUniversity of California Los Angeles
Los Angeles, California, United States
RecruitingSutter Medical Center
Sacramento, California, United States
RecruitingStanford University Medical Center
Stanford, California, United States
RecruitingUC Health Northern Colorado/Medical Center of the Rockies
Loveland, Colorado, United States
RecruitingHartford Hospital
Hartford, Connecticut, United States
RecruitingEmory University Hospital
Atlanta, Georgia, United States
RecruitingNorthwestern University Hospital
Chicago, Illinois, United States
RecruitingRush University Medical Center
Chicago, Illinois, United States
RecruitingOchsner Clinic Foundation
New Orleans, Louisiana, United States
RecruitingBrigham and Women's Hospital
Boston, Massachusetts, United States
RecruitingHenry Ford Hospital
Detroit, Michigan, United States
RecruitingMayo Clinic
Rochester, Minnesota, United States
RecruitingWashington University/ Barnes-Jewish Hospital
St Louis, Missouri, United States
RecruitingNewark Beth Israel
Newark, New Jersey, United States
RecruitingWinthrop University Hospital
Mineola, New York, United States
RecruitingCornell University
New York, New York, United States
RecruitingColumbia University Medical Center/ New York Presbyterian Hospital
New York, New York, United States
RecruitingThe Christ Hospital
Cincinnati, Ohio, United States
RecruitingThe Cleveland Clinic Foundation
Cleveland, Ohio, United States
RecruitingProvidence Heart & Vascular Institute
Portland, Oregon, United States
RecruitingUniversity of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
RecruitingAllegheny General Hospital
Pittsburgh, Pennsylvania, United States
RecruitingLankenau Medical Center
Wynnewood, Pennsylvania, United States
RecruitingMedical City Dallas Hospital
Dallas, Texas, United States
RecruitingThe Heart Hospital Baylor Plano
Dallas, Texas, United States
RecruitingThe University of Texas Health Science Center at Houston
Houston, Texas, United States
RecruitingIntermountain Medical Center
Murray, Utah, United States
RecruitingSentara Cardiovascular Research Institute
Norfolk, Virginia, United States
RecruitingKaiser Permanente San Francisco
San Francisco, California, United States
WithdrawnJFK Medical Center/ Atlantic Clinical Research Collaborative
Atlantis, Florida, United States
WithdrawnUniversity of Florida, Gainesville
Gainesville, Florida, United States
WithdrawnNorthshore University HealthSystem
Evanston, Illinois, United States
WithdrawnPrairie Education and Research Cooperative
Springfield, Illinois, United States
WithdrawnWilliam Beaumont Hospital
Royal Oak, Michigan, United States
WithdrawnUniversity of Minnesota Medical Center
Minneapolis, Minnesota, United States
WithdrawnSaint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, United States
WithdrawnNebraska Heart Institute
Lincoln, Nebraska, United States
WithdrawnDartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
WithdrawnUniversity of Buffalo
Buffalo, New York, United States
WithdrawnNew York University (NYU) Langone Medical Center
New York, New York, United States
WithdrawnCarolina's Health System
Charlotte, North Carolina, United States
WithdrawnNC Heart and Vascular (Rex Hospital)
Raleigh, North Carolina, United States
WithdrawnOklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States
WithdrawnBaptist Memorial Hospital
Memphis, Tennessee, United States
WithdrawnSaint Thomas Health Services
Nashville, Tennessee, United States
WithdrawnAustin Heart, PLLC
Austin, Texas, United States
WithdrawnUniversity of Virginia
Charlottesville, Virginia, United States
WithdrawnInova Heart and vascular Instritute (Fairfax Inova)
Fairfax, Virginia, United States
WithdrawnUniversity of Wisconsin - Madison
Madison, Wisconsin, United States
Withdrawn
1 site outside the US
St. Paul's Hospital, Providence Health Care
Vancouver, British Columbia, Canada
Recruiting
Study team
Sponsor
Edwards Lifesciences
Study ID 2015-08 AVIV
Principal investigator
Chris S Malaisrie, MD
Northwestern University Feinberg School of Medicine
Principal investigator
Alan Zajarias, MD
Washington University School of Medicine
Principal investigator
Mayra Guerrero, MD
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.