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THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial (PARTNER)

Primary Purpose

Critical Aortic Stenosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Edwards SAPIEN Transcatheter Heart Valve
Surgical Valve Replacement
medical management and/or balloon aortic valvuloplasty
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Aortic Stenosis focused on measuring Valvular Heart Disease, Critical/Severe Aortic Stenosis, High risk symptomatic patients

Eligibility Criteria

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

Inclusion Criteria Cohort A

  1. Patients must have co-morbidities such that the surgeon and cardiologist Co-PIs concur that the predicted risk of operative mortality is ≥15% and/or a minimum STS score of 10
  2. Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of < 0.8 cm2
  3. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater
  4. The subject or the subject'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 IRB of the respective clinical site

  5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits

    Cohort B All candidates for Cohort B of this study must meet #2, 3, 4, 5 of the above criteria and

  6. The subject, after formal consults by a cardiologist and two cardiovascular surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%.

Exclusion Criteria

  1. Evidence of an acute myocardial infarction ≤ 1month before the intended treatment.
  2. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified
  3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
  4. Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent implantation).
  5. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.

Sites / Locations

  • Scripps Memorial Hospital/Scripps Green Hospital
  • Cedars Sinai Medical Center
  • Stanford University Medical Center
  • Washington Hospital Center
  • University of Miami
  • Emory University Hospital
  • Northwestern University
  • NorthShore University HealthSystem
  • Ochsner Clinic
  • Boston Mass General
  • Brigham and Women's
  • Mayo Clinic-Saint Marys Hospital
  • St. Luke's Hospital of Kansas City
  • Barnes-Jewish/Washington University
  • New York Presbyterian Hospital - Cornell
  • Columbia University Medical Center
  • The Cleveland Clinic Foundation
  • University of Pennsylvania
  • Medical City Dallas
  • Intermountain Medical Center
  • University of Virginia
  • University of Washington
  • Vancouver St. Paul's
  • Toronto General Hospital
  • Laval Hospital
  • Heart Center Leipzig

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

1

2

3

4

Arm Description

Cohort A: Sapien Valve

Cohort A: other surgical valve

Cohort B: Sapien Valve

Cohort B: Medical therapy

Outcomes

Primary Outcome Measures

Death
Death from any cause.
Composite of Death and Recurrence Hospitalization.
Death from any cause or repeat hospitalization after intervention.

Secondary Outcome Measures

Functional Change of NYHA
NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (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.
Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)
Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure
Total Hospital Days From the Index Procedure
Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.
Change in Quality of Life (QOL) From Baseline to 1 Year
The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status. SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.

Full Information

First Posted
September 14, 2007
Last Updated
August 14, 2017
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT00530894
Brief Title
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
Acronym
PARTNER
Official Title
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2007 (Actual)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the safety and effectiveness of the device and delivery systems (transfemoral and transapical) in high risk, symptomatic patients with severe aortic stenosis.
Detailed Description
Subjects will undergo a physical exam and screening tests will be performed to determine if they are either A) a patient with a high surgical risk or B) not a candidate for surgery. They will then be randomized (like the flip of a coin) to have the investigational device implanted or to receive the current surgical or medical management available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Aortic Stenosis
Keywords
Valvular Heart Disease, Critical/Severe Aortic Stenosis, High risk symptomatic patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1057 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cohort A: Sapien Valve
Arm Title
2
Arm Type
Active Comparator
Arm Description
Cohort A: other surgical valve
Arm Title
3
Arm Type
Experimental
Arm Description
Cohort B: Sapien Valve
Arm Title
4
Arm Type
Active Comparator
Arm Description
Cohort B: Medical therapy
Intervention Type
Device
Intervention Name(s)
Edwards SAPIEN Transcatheter Heart Valve
Intervention Type
Device
Intervention Name(s)
Surgical Valve Replacement
Intervention Type
Other
Intervention Name(s)
medical management and/or balloon aortic valvuloplasty
Primary Outcome Measure Information:
Title
Death
Description
Death from any cause.
Time Frame
1 Year
Title
Composite of Death and Recurrence Hospitalization.
Description
Death from any cause or repeat hospitalization after intervention.
Time Frame
duration of study
Secondary Outcome Measure Information:
Title
Functional Change of NYHA
Description
NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (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
Baseline to 1 year
Title
Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)
Description
Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure
Time Frame
1 year
Title
Total Hospital Days From the Index Procedure
Description
Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.
Time Frame
1 year
Title
Change in Quality of Life (QOL) From Baseline to 1 Year
Description
The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status. SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.
Time Frame
Baseline and 1 Year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Cohort A Patients must have co-morbidities such that the surgeon and cardiologist Co-PIs concur that the predicted risk of operative mortality is ≥15% and/or a minimum STS score of 10 Patient has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of < 0.8 cm2 Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater The subject or the subject'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 IRB of the respective clinical site The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits Cohort B All candidates for Cohort B of this study must meet #2, 3, 4, 5 of the above criteria and The subject, after formal consults by a cardiologist and two cardiovascular surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the probability of death or serious, irreversible morbidity should exceed 50%. Exclusion Criteria Evidence of an acute myocardial infarction ≤ 1month before the intended treatment. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+). Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent implantation). Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin B Leon, MD
Organizational Affiliation
New York-Presbyterian Hospital/Columbia University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig Smith, MD
Organizational Affiliation
New York-Presbyterian Hospital/Columbia University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Memorial Hospital/Scripps Green 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
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Washington Hospital Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20010
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
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ochsner Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Boston Mass General
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
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 of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Barnes-Jewish/Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
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
22908
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Vancouver St. Paul's
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Laval Hospital
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Heart Center Leipzig
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

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