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The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B (PARTNERII B)

Primary Purpose

Severe, Symptomatic, Calcific Aortic Stenosis

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

About this trial

This is an interventional treatment trial for Severe focused on measuring SAPIEN, TAVR, THV, Aortic Stenosis, Heart Valve Disease, Aortic Valve, Retroflex, SAPIEN XT

Eligibility Criteria

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

Inclusion Criteria

  1. Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
  2. The probability of death or serious, irreversible morbidity is greater than or equal to 50%.
  3. The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient.
  4. The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
  5. The study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up.

Exclusion Criteria

  1. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified.
  2. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral)
  3. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
  4. It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis.
  5. Active bacterial endocarditis within 6 months (180 days) of procedure.

Sites / Locations

  • Arkansas Heart Hospital/Clinic
  • Scripps Green Hospital
  • Scripps Memorial Hospital
  • Cedars-Sinai Medical Center
  • Mercy General Hospital
  • Stanford University Medical Center
  • University of Colorado Hospital
  • Washington Hospital Center (WHC)
  • Morton Plant Hospital
  • University of Florida, Gainesville
  • University of Miami
  • Emory University Hospital
  • Northwestern Hospital
  • Rush University Medical Center
  • Prairie Education and Research Cooperative
  • Indiana University Health-Methodist Hospital
  • The University of Iowa
  • University of Louisville - Jewish Hospital
  • Ochsner Clinic Foundation
  • University of Maryland Medical Center
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Henry Ford Hospital
  • William Beaumont Hospital
  • Minneapolis Heart Institute Foundation
  • Mayo Clinic
  • Saint Luke's Hospital of Kansas City Mid America
  • Washington University - Barnes Jewish Hospital
  • Nebraska Heart Institute
  • Dartmouth-Hitchcock Medical Center
  • Newark Beth Israel
  • North Shore University Hospital, NY
  • Winthrop University Hospital
  • Cornell University
  • Columbia University Medical Center
  • Medical University of South Carolina Charleston
  • East Carolina Heart Institute at East Carolina University
  • The Christ Hospital, Cincinnati
  • Cleveland Clinic Foundation
  • Oklahoma Heart Hospital
  • University of Pennsylvania Hospital
  • York Hospital
  • Baptist Memorial Hospital
  • Austin Heart, PLLC
  • The Heart Hospital Baylor Plano
  • Medical City Dallas Hospital
  • The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
  • University of Texas Health Science Center at San Antonio (UTHSCSA)
  • Intermountain Medical Center
  • University of Virginia
  • Sentara Norfolk General Hospital
  • University of Washington
  • University of Wisconsin - Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TAVR - SAPIEN XT

TAVR - SAPIEN

Arm Description

TAVR (transaortic valve replacement) with SAPIEN XT

TAVR (transaortic valve replacement) with SAPIEN is the control arm

Outcomes

Primary Outcome Measures

Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization
All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year

Secondary Outcome Measures

NYHA Classification - Change From Baseline
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.
Total Aortic Regurgitation - Change From Baseline
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 one year was analyzed in the valve implant population.
Effective Orifice Area - Change From Baseline

Full Information

First Posted
January 17, 2014
Last Updated
August 27, 2018
Sponsor
Edwards Lifesciences
Collaborators
American College of Cardiology
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1. Study Identification

Unique Protocol Identification Number
NCT02184442
Brief Title
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
Acronym
PARTNERII B
Official Title
The PARTNER II Trial "Placement of AoRTic TraNscathetER" Valves Trial" (US) [PII B] for Inoperable Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 9, 2011 (Actual)
Primary Completion Date
May 1, 2013 (Actual)
Study Completion Date
May 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
Collaborators
American College of Cardiology

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 study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
Detailed Description
Cohort B was a 1:1 randomized, controlled study independently powered to compare transcatheter heart valve therapy with the first generation (SAPIEN™ THV) system to transcatheter heart valve therapy with the second generation (SAPIEN XT THV) system in patients who could not undergo surgery (inoperable). Patients in the control arm of Cohort B received an Edwards SAPIEN THV with the associated delivery system while patients in the treatment arm of Cohort B received an Edwards SAPIEN XT THV with the associated delivery system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe, Symptomatic, Calcific Aortic Stenosis
Keywords
SAPIEN, TAVR, THV, Aortic Stenosis, Heart Valve Disease, Aortic Valve, Retroflex, SAPIEN XT

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
TAVR - SAPIEN XT
Arm Type
Experimental
Arm Description
TAVR (transaortic valve replacement) with SAPIEN XT
Arm Title
TAVR - SAPIEN
Arm Type
Active Comparator
Arm Description
TAVR (transaortic valve replacement) with SAPIEN is the control arm
Intervention Type
Device
Intervention Name(s)
TAVR Implantation with SAPIEN XT
Intervention Description
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Intervention Type
Device
Intervention Name(s)
TAVR Implantation with SAPIEN
Intervention Description
Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Primary Outcome Measure Information:
Title
Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization
Description
All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
NYHA Classification - Change From Baseline
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
Baseline and 1 Year
Title
Total Aortic Regurgitation - Change From Baseline
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 one year was analyzed in the valve implant population.
Time Frame
1 Year
Title
Effective Orifice Area - Change From Baseline
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patient was symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater. The probability of death or serious, irreversible morbidity is greater than or equal to 50%. The heart team agreed (and verified in the case review process) that valve implantation would likely benefit the patient. The study patient or the study patient's legal representative was informed of the nature of the study, agreed to its provisions and had provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. The study patient agreed to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which was conducted as a phone follow-up. Exclusion Criteria Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified. Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (> 5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta. (Transfemoral) Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. It is known that the patient is currently enrolled in the PARTNER I Trial or was withdrawn from the PARTNER I Trial prior to endpoint analysis. Active bacterial endocarditis within 6 months (180 days) of procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin B Leon, 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
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 (WHC)
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 Florida, Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwestern Hospital
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
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
University of Louisville - Jewish Hospital
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 Medical Center
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
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City Mid America
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
Newark Beth Israel
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
North Shore University Hospital, NY
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Cornell University
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
Medical University of South Carolina Charleston
City
Charleston
State/Province
North Carolina
ZIP/Postal Code
29425
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 Christ Hospital, Cincinnati
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 Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
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
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 Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
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
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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35656983
Citation
Shahim B, Redfors B, Lindman BR, Chen S, Dahlen T, Nazif T, Kapadia S, Gertz ZM, Crowley AC, Li D, Thourani VH, Kodali SK, Zajarias A, Babaliaros VC, Guyton RA, Elmariah S, Herrmann HC, Cohen DJ, Mack MJ, Smith CR, Leon MB, George I. Neutrophil-to-Lymphocyte Ratios in Patients Undergoing Aortic Valve Replacement: The PARTNER Trials and Registries. J Am Heart Assoc. 2022 Jun 7;11(11):e024091. doi: 10.1161/JAHA.121.024091. Epub 2022 Jun 3.
Results Reference
derived
PubMed Identifier
35595203
Citation
Genereux P, Pibarot P, Redfors B, Bax JJ, Zhao Y, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Vincent F, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Cohen DJ. Evolution and Prognostic Impact of Cardiac Damage After Aortic Valve Replacement. J Am Coll Cardiol. 2022 Aug 23;80(8):783-800. doi: 10.1016/j.jacc.2022.05.006. Epub 2022 May 17.
Results Reference
derived
PubMed Identifier
31883339
Citation
Chen S, Redfors B, O'Neill BP, Clavel MA, Pibarot P, Elmariah S, Nazif T, Crowley A, Ben-Yehuda O, Finn MT, Alu MC, Vahl TP, Kodali S, Leon MB, Lindman BR. Low and elevated B-type natriuretic peptide levels are associated with increased mortality in patients with preserved ejection fraction undergoing transcatheter aortic valve replacement: an analysis of the PARTNER II trial and registry. Eur Heart J. 2020 Feb 21;41(8):958-969. doi: 10.1093/eurheartj/ehz892.
Results Reference
derived
PubMed Identifier
31690104
Citation
Summers MR, Leon MB, Smith CR, Kodali SK, Thourani VH, Herrmann HC, Makkar RR, Pibarot P, Webb JG, Leipsic J, Alu MC, Crowley A, Hahn RT, Kapadia SR, Tuzcu EM, Svensson L, Cremer PC, Jaber WA. Prosthetic Valve Endocarditis After TAVR and SAVR: Insights From the PARTNER Trials. Circulation. 2019 Dec 10;140(24):1984-1994. doi: 10.1161/CIRCULATIONAHA.119.041399. Epub 2019 Nov 6.
Results Reference
derived
PubMed Identifier
31525069
Citation
Furer A, Chen S, Redfors B, Elmariah S, Pibarot P, Herrmann HC, Hahn RT, Kodali S, Thourani VH, Douglas PS, Alu MC, Fearon WF, Passeri J, Malaisrie SC, Crowley A, McAndrew T, Genereux P, Ben-Yehuda O, Leon MB, Burkhoff D. Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials. Circ Heart Fail. 2019 Aug;12(8):e005809. doi: 10.1161/CIRCHEARTFAILURE.118.005809. Epub 2019 Aug 1.
Results Reference
derived

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The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B

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