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PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk (PII A)

Primary Purpose

Symptomatic Severe Aortic Stenosis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TAVR Implantation with SAPIEN XT
SAVR Implantation
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Symptomatic Severe Aortic Stenosis focused on measuring SAPIEN XT, Transfemoral, Transapical, Transaortic, NovaFlex, TAVI, Aortic Stenosis, THV, Aortic Valve, Transcatheter Heart Valve, TAVR

Eligibility Criteria

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

Inclusion Criteria

  1. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA < 0.5 cm2/m2 Qualifying echo must be within 60 days of the date of the procedure.
  2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  3. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient.
  4. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  5. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up.
  6. Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment.

Exclusion Criteria

  1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)].
  2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
  3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
  4. Preexisting mechanical or bioprosthetic valve in any position (except NR3).
  5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD (S3 Cohort only) is not excluded.
  6. Heart team assessment of inoperability (including examining cardiac surgeon).

Sites / Locations

  • Arkansas Heart Hospital/Clinic
  • Scripps Green Hospital
  • Scripps Memorial Hospital
  • Cedars-Sinai Medical Center
  • Mercy General Hospital
  • UC Davis Medical Center
  • Stanford University Medical Center
  • University of Colorado Hospital
  • Washington Hospital Center
  • Morton Plant Hospital
  • University of Miami Hospital Miller School of Medicine
  • Emory University
  • Northwestern University
  • Rush University Medical Center
  • Northshore
  • Prairie Education and Research Cooperative
  • Indiana University Health-Methodist Hospital
  • The University of Iowa
  • The Jewish Hospital Medical Center
  • Ochsner Clinic Foundation
  • University of Maryland, Baltimore
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Henry Ford Hospital
  • William Beaumont Hospital
  • Minneapolis Heart Institute Foundation
  • Mayo Clinic-Saint Marys Hospital
  • St. Luke's Hospital - Mid America Heart Institute
  • Washington University - Barnes Jewish Hospital
  • Nebraska Heart Institute
  • Dartmouth Hitchcock Medical Center
  • Cooper University
  • Newark Beth Israel Medical Center
  • Winthrop University Hospital
  • New York Presbyterian Hospital - Cornell
  • Columbia University Medical Center
  • East Carolina Heart Institute at East Carolina University
  • The Lindner Center for Research & Education at The Christ Hospital
  • Cleveland Clinic Foundation
  • Oklahoma Cardiovascular Research Group
  • Providence Heart & Vascular Institute at Providence St. Vincent Medical Center
  • University of Pennsylvania Hospital
  • York Hospital
  • Medical University of South Carolina
  • Baptist Memorial Hospital
  • Austin Heart, PLLC
  • The Heart Hospital Baylor Plano
  • Medical City Dallas
  • The University of Texas Health Science Center at Houston
  • University of Texas Health Science Center at San Antonio (UTHSCSA)
  • IHC Health Services Inc. dba Intermountain Medical Center
  • University of Virginia
  • Sentara Norfolk General Hospital
  • University of Washington
  • University of Wisconsin - Madison
  • St. Paul's Hospital, Providence Health Care
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PIIA - SAPIEN XT

Control: SAVR

Arm Description

PIIA is operable group

SAVR (surgical aortic valve replacement) is the control arm

Outcomes

Primary Outcome Measures

All-cause Death or Disabling Stroke to Two Years
All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)

Secondary Outcome Measures

Adjusted Days Alive and Out of Hospital (DAOH) to Two Years
The number of days the patients are alive and out of the hospital.
Total Aortic Regurgitation (AR) at 2 Years
Total aortic regurgitation was assessed by the core lab as "Grade 0" = None, "Grade 1+" = Trace, "Grade 2+" = Mild, "Grade 3+" = Moderate and "Grade 4+" = Severe. Total regurgitation at two year was analyzed in the valve implant population.
6MWT Change From Baseline
Six Minute Walk Test change from baseline to 2 years
NYHA Classification at 2 Years
New York Heart Association (NYHA), 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 as no limitations and the highest unable to carry on any physical activity without discomfort.
Effective Orifice Area (EOA)

Full Information

First Posted
March 7, 2011
Last Updated
August 15, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT01314313
Brief Title
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
Acronym
PII A
Official Title
Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2011 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
November 2024 (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
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
Detailed Description
The PIIA cohort is a prospective multi-center trial undergoing aortic valve replacement for severe aortic stenosis. Patients randomized to the treatment arm will receive an Edwards SAPIEN XT THV with either transfemoral, transapical or transaortic delivery access. Patients in the control arm will receive a surgical bioprosthetic heart valve via aortic valve replacement surgery. To assure that patients with an STS score ≥ 4% have been selected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Severe Aortic Stenosis
Keywords
SAPIEN XT, Transfemoral, Transapical, Transaortic, NovaFlex, TAVI, Aortic Stenosis, THV, Aortic Valve, Transcatheter Heart Valve, TAVR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2032 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PIIA - SAPIEN XT
Arm Type
Experimental
Arm Description
PIIA is operable group
Arm Title
Control: SAVR
Arm Type
Active Comparator
Arm Description
SAVR (surgical aortic valve replacement) is the control arm
Intervention Type
Device
Intervention Name(s)
TAVR Implantation with SAPIEN XT
Intervention Description
Operable Group with SAPIEN XT
Intervention Type
Device
Intervention Name(s)
SAVR Implantation
Intervention Description
Control Group
Primary Outcome Measure Information:
Title
All-cause Death or Disabling Stroke to Two Years
Description
All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Adjusted Days Alive and Out of Hospital (DAOH) to Two Years
Description
The number of days the patients are alive and out of the hospital.
Time Frame
2 years
Title
Total Aortic Regurgitation (AR) at 2 Years
Description
Total aortic regurgitation was assessed by the core lab as "Grade 0" = None, "Grade 1+" = Trace, "Grade 2+" = Mild, "Grade 3+" = Moderate and "Grade 4+" = Severe. Total regurgitation at two year was analyzed in the valve implant population.
Time Frame
2 years
Title
6MWT Change From Baseline
Description
Six Minute Walk Test change from baseline to 2 years
Time Frame
Baseline and 2 years
Title
NYHA Classification at 2 Years
Description
New York Heart Association (NYHA), 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 as no limitations and the highest unable to carry on any physical activity without discomfort.
Time Frame
2 years
Title
Effective Orifice Area (EOA)
Time Frame
2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA < 0.5 cm2/m2 Qualifying echo must be within 60 days of the date of the procedure. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient. The study patient or the study patient's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up. Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if randomized to control treatment. Exclusion Criteria Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)]. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+). Preexisting mechanical or bioprosthetic valve in any position (except NR3). Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker or ICD (S3 Cohort only) is not excluded. Heart team assessment of inoperability (including examining cardiac surgeon).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin B Leon, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig Smith, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Heart Hospital/Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Scripps Memorial Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of Miami Hospital Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Northshore
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Indiana University Health-Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
The Jewish Hospital Medical Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic-Saint Marys Hospital
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Luke's Hospital - Mid America Heart Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University - Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cooper University
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
New York Presbyterian Hospital - Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
East Carolina Heart Institute at East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
The Lindner Center for Research & Education at The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oklahoma Cardiovascular Research Group
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Providence Heart & Vascular Institute at Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Austin Heart, PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Dallas
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio (UTHSCSA)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
IHC Health Services Inc. dba Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
St. Paul's Hospital, Providence Health Care
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec
ZIP/Postal Code
G1V465
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

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