RECRUITING

PARTNER 3 Trial - Aortic Valve-in-Valve

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Conditions

Aortic StenosisAortic Stenosis, SevereSAPIEN 3PARTNER 3cardiovascular diseaseheart diseaseSAVRTAVRfailing surgical valvefailing bioprosthetic valvefailing valveSAPIEN 3 Ultra

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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

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.

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

Quick Facts

Study Start:2017-01-05
Study Completion:2038-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03003299

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 CriteriaExclusion Criteria
  1. 1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
  2. 2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
  3. 3. NYHA Functional Class ≥ II.
  4. 4. Heart Team agrees the patient is low to intermediate risk.
  5. 5. Heart Team agrees valve implantation will likely benefit the patient.
  6. 6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
  1. 1. Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
  2. 2. Severe regurgitation (\> 3+) or stenosis of any other valve
  3. 3. Failing valve has moderate or severe paravalvular regurgitation
  4. 4. Failing valve is unstable, rocking, or not structurally intact
  5. 5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
  6. 6. Increased risk of embolization of THV
  7. 7. Known bioprosthetic valve with residual mean gradient \> 20 mmHg at the end of the index procedure for implantation of the original valve
  8. 8. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
  9. 9. Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
  10. 10. Anatomical characteristics that would preclude safe access to the apex (Transapical)
  11. 11. Evidence of an acute myocardial infarction ≤ 30 days before enrollment
  12. 12. 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.
  13. 13. Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
  14. 14. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
  15. 15. Untreated clinically significant coronary artery disease requiring revascularization
  16. 16. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
  17. 17. Emergency interventional/surgical procedures within 30 days prior to the procedure
  18. 18. Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure
  19. 19. Hypertrophic cardiomyopathy with obstruction
  20. 20. LVEF \< 30%
  21. 21. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
  22. 22. Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
  23. 23. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
  24. 24. Stroke or transient ischemic attack within 90 days of enrollment
  25. 25. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
  26. 26. Renal insufficiency and/or renal replacement therapy at the time of screening
  27. 27. Active bacterial endocarditis within 180 days of the procedure
  28. 28. Patient refuses blood products
  29. 29. Estimated life expectancy \< 24 months
  30. 30. Positive urine or serum pregnancy test in female subjects of childbearing potential
  31. 31. Currently participating in an investigational drug or another device study

Contacts and Locations

Study Contact

Edwards THV Clinical Affairs
CONTACT
(949) 250-2500
THV_CT.gov@Edwards.com

Principal Investigator

Chris S Malaisrie, MD
PRINCIPAL_INVESTIGATOR
Northwestern University Feinberg School of Medicine
Alan Zajarias, MD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Mayra Guerrero, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Banner University Medical Center
Phoenix, Arizona, 85006
United States
University of California Los Angeles
Los Angeles, California, 90095
United States
Sutter Medical Center
Sacramento, California, 95919
United States
Kaiser Permanente San Francisco
San Francisco, California, 94115
United States
Stanford University Medical Center
Stanford, California, 94305
United States
UC Health Northern Colorado/Medical Center of the Rockies
Loveland, Colorado, 80538
United States
Hartford Hospital
Hartford, Connecticut, 06102
United States
JFK Medical Center/ Atlantic Clinical Research Collaborative
Atlantis, Florida, 33462
United States
University of Florida, Gainesville
Gainesville, Florida, 32610
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Northwestern University Hospital
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Northshore University HealthSystem
Evanston, Illinois, 60201
United States
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
William Beaumont Hospital
Royal Oak, Michigan, 48073
United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, 64111
United States
Washington University/ Barnes-Jewish Hospital
Saint Louis, Missouri, 63110
United States
Nebraska Heart Institute
Lincoln, Nebraska, 68526
United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States
Newark Beth Israel
Newark, New Jersey, 07112
United States
University of Buffalo
Buffalo, New York, 14203
United States
Winthrop University Hospital
Mineola, New York, 11501
United States
New York University (NYU) Langone Medical Center
New York, New York, 10016
United States
Cornell University
New York, New York, 10021
United States
Columbia University Medical Center/ New York Presbyterian Hospital
New York, New York, 10032
United States
Carolina's Health System
Charlotte, North Carolina, 28203
United States
NC Heart and Vascular (Rex Hospital)
Raleigh, North Carolina, 27607
United States
The Christ Hospital
Cincinnati, Ohio, 45219
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
United States
Providence Heart & Vascular Institute
Portland, Oregon, 97225
United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120
United States
Saint Thomas Health Services
Nashville, Tennessee, 37205
United States
Austin Heart, PLLC
Austin, Texas, 78756
United States
Medical City Dallas Hospital
Dallas, Texas, 75093
United States
The Heart Hospital Baylor Plano
Dallas, Texas, 75093
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
Intermountain Medical Center
Murray, Utah, 84157
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
Inova Heart and vascular Instritute (Fairfax Inova)
Fairfax, Virginia, 22042
United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507
United States
University of Wisconsin - Madison
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Edwards Lifesciences

  • Chris S Malaisrie, MD, PRINCIPAL_INVESTIGATOR, Northwestern University Feinberg School of Medicine
  • Alan Zajarias, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine
  • Mayra Guerrero, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

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 Date2017-01-05
Study Completion Date2038-04

Study Record Updates

Study Start Date2017-01-05
Study Completion Date2038-04

Terms related to this study

Keywords Provided by Researchers

  • SAPIEN 3
  • PARTNER 3
  • cardiovascular disease
  • heart disease
  • aortic stenosis
  • SAVR
  • TAVR
  • failing surgical valve
  • failing bioprosthetic valve
  • failing valve
  • SAPIEN 3 Ultra

Additional Relevant MeSH Terms

  • Aortic Stenosis
  • Aortic Stenosis, Severe