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PARTNER 3 Trial - Aortic Valve-in-Valve

Primary Purpose

Aortic Stenosis, Aortic Stenosis, Severe

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring SAPIEN 3, PARTNER 3, cardiovascular disease, heart disease, aortic stenosis, SAVR, TAVR, failing surgical valve, failing bioprosthetic valve, failing valve, SAPIEN 3 Ultra

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner University Medical CenterRecruiting
  • University of California Los AngelesRecruiting
  • Sutter Medical CenterRecruiting
  • Kaiser Permanente San Francisco
  • Stanford University Medical CenterRecruiting
  • UC Health Northern Colorado/Medical Center of the RockiesRecruiting
  • Hartford HospitalRecruiting
  • JFK Medical Center/ Atlantic Clinical Research Collaborative
  • University of Florida, Gainesville
  • Emory University HospitalRecruiting
  • Northwestern University HospitalRecruiting
  • Rush University Medical CenterRecruiting
  • Northshore University HealthSystem
  • Prairie Education and Research Cooperative
  • Ochsner Clinic FoundationRecruiting
  • Brigham and Women's HospitalRecruiting
  • Henry Ford HospitalRecruiting
  • William Beaumont Hospital
  • University of Minnesota Medical Center
  • Mayo ClinicRecruiting
  • Saint Luke's Hospital of Kansas City Mid America
  • Washington University/ Barnes-Jewish HospitalRecruiting
  • Nebraska Heart Institute
  • Dartmouth-Hitchcock Medical Center
  • Newark Beth IsraelRecruiting
  • University of Buffalo
  • Winthrop University HospitalRecruiting
  • New York University (NYU) Langone Medical Center
  • Cornell UniversityRecruiting
  • Columbia University Medical Center/ New York Presbyterian HospitalRecruiting
  • Carolina's Health System
  • NC Heart and Vascular (Rex Hospital)
  • The Christ HospitalRecruiting
  • The Cleveland Clinic FoundationRecruiting
  • Oklahoma Cardiovascular Research Group
  • Providence Heart & Vascular InstituteRecruiting
  • University of Pennsylvania HospitalRecruiting
  • Allegheny General HospitalRecruiting
  • Lankenau Medical CenterRecruiting
  • Baptist Memorial Hospital
  • Saint Thomas Health Services
  • Austin Heart, PLLC
  • Medical City Dallas HospitalRecruiting
  • The Heart Hospital Baylor PlanoRecruiting
  • The University of Texas Health Science Center at HoustonRecruiting
  • Intermountain Medical CenterRecruiting
  • University of Virginia
  • Inova Heart and vascular Instritute (Fairfax Inova)
  • Sentara Cardiovascular Research InstituteRecruiting
  • University of Wisconsin - Madison
  • St. Paul's Hospital, Providence Health CareRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAVR - Failing surgical or transcatheter valve

Arm Description

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

Outcomes

Primary Outcome Measures

Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
Number of patients that died and/or had a stroke

Secondary Outcome Measures

Mean gradient
Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
Peak gradient
Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.
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.
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.
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.

Full Information

First Posted
December 19, 2016
Last Updated
May 1, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT03003299
Brief Title
PARTNER 3 Trial - Aortic Valve-in-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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
January 2033 (Anticipated)
Study Completion Date
April 2038 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAVR - Failing surgical or transcatheter valve
Arm Type
Experimental
Arm Description
Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).
Intervention Type
Device
Intervention Name(s)
Edwards SAPIEN 3/SAPIEN 3 Ultra THV
Intervention Description
Edwards SAPIEN 3/SAPIEN 3 Ultra THV system with the associated delivery systems.
Primary Outcome Measure Information:
Title
Safety and Effectiveness - Non-hierarchical composite of all-cause mortality and stroke
Description
Number of patients that died and/or had a stroke
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mean gradient
Description
Measures the mean aortic pressure gradient from the measured velocity. Units used are mmHg.
Time Frame
30 days
Title
Peak gradient
Description
Measures the peak aortic pressure gradient from the measured velocity. Units used are mmHg.
Time Frame
30 days
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Description
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.
Time Frame
30 days
Title
New York Heart Association (NYHA) Classification
Description
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.
Time Frame
30 days
Title
Six-Minute Walk Test (6MWT)
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edwards THV Clinical Affairs
Phone
(949) 250-2500
Email
THV_CT.gov@Edwards.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris S Malaisrie, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan Zajarias, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mayra Guerrero, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner University Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Sutter Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95919
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Individual Site Status
Withdrawn
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Health Northern Colorado/Medical Center of the Rockies
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Individual Site Status
Recruiting
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Recruiting
Facility Name
JFK Medical Center/ Atlantic Clinical Research Collaborative
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Florida, Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Withdrawn
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwestern University Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
Northshore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Withdrawn
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Withdrawn
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Saint Luke's Hospital of Kansas City Mid America
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Withdrawn
Facility Name
Washington University/ Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Nebraska Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Individual Site Status
Withdrawn
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Withdrawn
Facility Name
Newark Beth Israel
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Withdrawn
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Name
New York University (NYU) Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center/ New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina's Health System
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Withdrawn
Facility Name
NC Heart and Vascular (Rex Hospital)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Withdrawn
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Oklahoma Cardiovascular Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Withdrawn
Facility Name
Providence Heart & Vascular Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Individual Site Status
Withdrawn
Facility Name
Saint Thomas Health Services
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Withdrawn
Facility Name
Austin Heart, PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Individual Site Status
Withdrawn
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
The Heart Hospital Baylor Plano
City
Dallas
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Withdrawn
Facility Name
Inova Heart and vascular Instritute (Fairfax Inova)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Withdrawn
Facility Name
Sentara Cardiovascular Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Withdrawn
Facility Name
St. Paul's Hospital, Providence Health Care
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PARTNER 3 Trial - Aortic Valve-in-Valve

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