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

August 14, 2017 updated by: Edwards Lifesciences

THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1057

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Laval Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Vancouver St. Paul's
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
  • Germany
      • Leipzig, Germany, 04289
        • Heart Center Leipzig
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Memorial Hospital/Scripps Green Hospital
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's
      • Boston, Massachusetts, United States, 02114
        • Boston Mass General
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic-Saint Marys Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital of Kansas City
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish/Washington University
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital - Cornell
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75230
        • Medical City Dallas
    • Utah
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98101
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Cohort A: Sapien Valve
Device: Edwards SAPIEN Transcatheter Heart Valve
Active Comparator: 2
Cohort A: other surgical valve
Device: Surgical Valve Replacement
Experimental: 3
Cohort B: Sapien Valve
Device: Edwards SAPIEN Transcatheter Heart Valve
Active Comparator: 4
Cohort B: Medical therapy
Other: medical management and/or balloon aortic valvuloplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 1 Year
Death from any cause.
1 Year
Composite of Death and Recurrence Hospitalization.
Time Frame: duration of study
Death from any cause or repeat hospitalization after intervention.
duration of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Change of NYHA
Time Frame: Baseline to 1 year
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.
Baseline to 1 year
Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)
Time Frame: 1 year
Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure
1 year
Total Hospital Days From the Index Procedure
Time Frame: 1 year
Total hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.
1 year
Change in Quality of Life (QOL) From Baseline to 1 Year
Time Frame: Baseline and 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.
Baseline and 1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Martin B Leon, MD, New York-Presbyterian Hospital/Columbia University Medical Center
  • Principal Investigator: Craig Smith, MD, New York-Presbyterian Hospital/Columbia University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

September 14, 2007

First Submitted That Met QC Criteria

September 14, 2007

First Posted (Estimate)

September 18, 2007

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-06-US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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