PARTNER 3 Trial - Aortic Valve-in-Valve

NCT03003299 | Recruiting DMC FDA Device

• 1 other identifier: 2015-08 AVIV
• Study Type: interventional
• Target: 125
• Locations: 2 countries
• Sites: 51

Brief Summary

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.

Conditions

Aortic Stenosis; Aortic Stenosis, Severe

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mean gradient

  30 days

• Peak gradient

  30 days

• Kansas City Cardiomyopathy Questionnaire (KCCQ)

  30 days

• New York Heart Association (NYHA) Classification

  30 days

• Six-Minute Walk Test (6MWT)

  30 days

Study Arms (1)

TAVR - Failing surgical or transcatheter valve

EXPERIMENTAL

Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).

Device: Edwards SAPIEN 3/SAPIEN 3 Ultra THV

Interventions

Edwards SAPIEN 3/SAPIEN 3 Ultra THV DEVICE

Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.

TAVR - Failing surgical or transcatheter valve

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You 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 may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (51)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

RECRUITING

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Sutter Medical Center

Sacramento, California, 95919, United States

RECRUITING

Kaiser Permanente San Francisco

San Francisco, California, 94115, United States

WITHDRAWN

Stanford University Medical Center

Stanford, California, 94305, United States

RECRUITING

UC Health Northern Colorado/Medical Center of the Rockies

Loveland, Colorado, 80538, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

JFK Medical Center/ Atlantic Clinical Research Collaborative

Atlantis, Florida, 33462, United States

WITHDRAWN

University of Florida, Gainesville

Gainesville, Florida, 32610, United States

WITHDRAWN

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Northwestern University Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Northshore University HealthSystem

Evanston, Illinois, 60201, United States

WITHDRAWN

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

WITHDRAWN

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

WITHDRAWN

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

WITHDRAWN

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Saint Luke's Hospital of Kansas City Mid America

Kansas City, Missouri, 64111, United States

WITHDRAWN

Washington University/ Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

WITHDRAWN

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

WITHDRAWN

Newark Beth Israel

Newark, New Jersey, 07112, United States

RECRUITING

University of Buffalo

Buffalo, New York, 14203, United States

WITHDRAWN

Winthrop University Hospital

Mineola, New York, 11501, United States

RECRUITING

New York University (NYU) Langone Medical Center

New York, New York, 10016, United States

WITHDRAWN

Cornell University

New York, New York, 10021, United States

RECRUITING

Columbia University Medical Center/ New York Presbyterian Hospital

New York, New York, 10032, United States

RECRUITING

Carolina's Health System

Charlotte, North Carolina, 28203, United States

WITHDRAWN

NC Heart and Vascular (Rex Hospital)

Raleigh, North Carolina, 27607, United States

WITHDRAWN

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

WITHDRAWN

Providence Heart & Vascular Institute

Portland, Oregon, 97225, United States

RECRUITING

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

WITHDRAWN

Saint Thomas Health Services

Nashville, Tennessee, 37205, United States

WITHDRAWN

Austin Heart, PLLC

Austin, Texas, 78756, United States

WITHDRAWN

Medical City Dallas Hospital

Dallas, Texas, 75093, United States

RECRUITING

The Heart Hospital Baylor Plano

Dallas, Texas, 75093, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Intermountain Medical Center

Murray, Utah, 84157, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

WITHDRAWN

Inova Heart and vascular Instritute (Fairfax Inova)

Fairfax, Virginia, 22042, United States

WITHDRAWN

Sentara Cardiovascular Research Institute

Norfolk, Virginia, 23507, United States

RECRUITING

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

WITHDRAWN

St. Paul's Hospital, Providence Health Care

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Cardiovascular Diseases; Heart Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edwards THV Clinical Affairs

CONTACT

(949) 250-2500; THV_CT.gov@Edwards.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: December 28, 2016
• Study Start: January 5, 2017
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): April 1, 2038
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (50)