PARTNER 3 Trial - Aortic Valve-in-Valve

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis; Aortic Stenosis, Severe
• Intervention / Treatment: Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THV

Detailed Description

This is a prospective, single-arm, multicenter study.

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edwards THV Clinical Affairs; Phone Number: (949) 250-2500; Email: THV_CT.gov@Edwards.com

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Recruiting
      • St. Paul's Hospital, Providence Health Care
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Recruiting
      • Banner University Medical Center
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • University of California Los Angeles
    • Sacramento, California, United States, 95919
      • Recruiting
      • Sutter Medical Center
    • San Francisco, California, United States, 94115
      • Withdrawn
      • Kaiser Permanente San Francisco
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University Medical Center
  • Colorado
    • Loveland, Colorado, United States, 80538
      • Recruiting
      • UC Health Northern Colorado/Medical Center of the Rockies
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Recruiting
      • Hartford Hospital
  • Florida
    • Atlantis, Florida, United States, 33462
      • Withdrawn
      • JFK Medical Center/ Atlantic Clinical Research Collaborative
    • Gainesville, Florida, United States, 32610
      • Withdrawn
      • University of Florida, Gainesville
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern University Hospital
    • Evanston, Illinois, United States, 60201
      • Withdrawn
      • Northshore University Healthsystem
    • Springfield, Illinois, United States, 62701
      • Withdrawn
      • Prairie Education and Research Cooperative
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Recruiting
      • Ochsner Clinic Foundation
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
    • Royal Oak, Michigan, United States, 48073
      • Withdrawn
      • William Beaumont Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Withdrawn
      • University of Minnesota Medical Center
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Withdrawn
      • Saint Luke's Hospital of Kansas City Mid America
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University/ Barnes-Jewish Hospital
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Withdrawn
      • Nebraska Heart Institute
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Withdrawn
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Newark, New Jersey, United States, 07112
      • Recruiting
      • Newark Beth Israel
  • New York
    • Buffalo, New York, United States, 14203
      • Withdrawn
      • University of Buffalo
    • Mineola, New York, United States, 11501
      • Recruiting
      • Winthrop University Hospital
    • New York, New York, United States, 10021
      • Recruiting
      • Cornell University
    • New York, New York, United States, 10016
      • Withdrawn
      • New York University (NYU) Langone Medical Center
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center/ New York Presbyterian Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Withdrawn
      • Carolina's Health System
    • Raleigh, North Carolina, United States, 27607
      • Withdrawn
      • NC Heart and Vascular (Rex Hospital)
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • The Cleveland Clinic Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Withdrawn
      • Oklahoma Cardiovascular Research Group
  • Oregon
    • Portland, Oregon, United States, 97225
      • Recruiting
      • Providence Heart & Vascular Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Recruiting
      • Allegheny General Hospital
    • Wynnewood, Pennsylvania, United States, 19096
      • Recruiting
      • Lankenau Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Withdrawn
      • Baptist Memorial Hospital
    • Nashville, Tennessee, United States, 37205
      • Withdrawn
      • Saint Thomas Health Services
  • Texas
    • Austin, Texas, United States, 78756
      • Withdrawn
      • Austin Heart, PLLC
    • Dallas, Texas, United States, 75093
      • Recruiting
      • Medical City Dallas Hospital
    • Dallas, Texas, United States, 75093
      • Recruiting
      • The Heart Hospital Baylor Plano
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
  • Utah
    • Murray, Utah, United States, 84157
      • Recruiting
      • Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Withdrawn
      • University of Virginia
    • Fairfax, Virginia, United States, 22042
      • Withdrawn
      • Inova Heart and vascular Instritute (Fairfax Inova)
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Sentara Cardiovascular Research Institute
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Withdrawn
      • University of Wisconsin - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
3. NYHA Functional Class ≥ II.
4. Heart Team agrees the patient is low to intermediate risk.
5. Heart Team agrees valve implantation will likely benefit the patient.
6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAVR - Failing surgical or transcatheter valve; Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).	Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THV; Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke	Number of patients that died and/or had a stroke	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean gradient	Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.	30 days
Peak gradient	Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.	30 days
Kansas City Cardiomyopathy Questionnaire (KCCQ)	Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life.	30 days
New York Heart Association (NYHA) Classification	Change from baseline in NYHA. NYHA is a functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.	30 days
Six-Minute Walk Test (6MWT)	Change from baseline in 6MWT. The 6-Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.	30 days

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Mayra Guerrero, MD, Mayo Clinic; Principal Investigator: Alan Zajarias, MD, Washington University School of Medicine; Principal Investigator: Chris S Malaisrie, MD, Northwestern University Feinberg School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2017
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): April 1, 2038

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimated): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: cardiovascular disease; aortic stenosis; heart disease; TAVR; SAPIEN 3; SAVR; SAPIEN 3 Ultra; PARTNER 3; failing valve; failing bioprosthetic valve; failing surgical valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 2015-08 AVIV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes