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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00530894
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : May 11, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE September 14, 2007
First Posted Date  ICMJE September 18, 2007
Results First Submitted Date March 7, 2016
Results First Posted Date May 11, 2017
Last Update Posted Date September 13, 2017
Actual Study Start Date  ICMJE April 2007
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
  • Death [ Time Frame: 1 Year ]
    Death from any cause.
  • Composite of Death and Recurrence Hospitalization. [ Time Frame: duration of study ]
    Death from any cause or repeat hospitalization after intervention.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
  • Freedom from death (Cohort A: Edwards Sapien Valve vs. other surgical valve) [ Time Frame: 1 Year ]
  • Freedom from Death (Cohort B: Edwards Sapien Valve vs. medical therapy) [ Time Frame: duration of study ]
Change History Complete list of historical versions of study NCT00530894 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2017)
  • 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.
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
  • Functional Improvement from baseline per NYHA functional classification (Cohort A and Cohort B) [ Time Frame: 30 days, 6 months, 1 year ]
  • Freedom from MACCE defined as death, myocardial infarction, stroke, or aortic valve reintervention (Cohort A and Cohort B) [ Time Frame: 30 days, 6 months, 1 year ]
  • Evidence of prosthetic valve dysfunction (hemolysis, infection, thrombosis, sever paravalvular leak, or migration) (Cohort A) [ Time Frame: 30 days, 6 months, 1 year ]
  • Length of index hospital stay (Cohort A) [ Time Frame: number of days hospitalized ]
  • Total hospital days from the index procedure to one year post procedure. (Cohort A) [ Time Frame: 1 year ]
  • Improved Quality of Life (QOL) from baseline to 30 days, 6 months, and 1 year (Cohort A and Cohort B) [ Time Frame: 30 days, 6 months, 1 year ]
  • Improved valve function demonstrated by a responder analysis showing the percentage of patients in each treatment group who have a greater than 50% improvement in AVA at 30 days, 6 months, and 12 months. (Cohort A and Cohort B) [ Time Frame: 30 days, 6 months, 1 year ]
  • Total hospital days from the index procedure or randomization in to control arm for medical management patients to 1 year post procedure or randomization (Cohort B) [ Time Frame: 1 year ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
Official Title  ICMJE THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve
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.
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Critical Aortic Stenosis
Intervention  ICMJE
  • Device: Edwards SAPIEN Transcatheter Heart Valve
  • Device: Surgical Valve Replacement
  • Other: medical management and/or balloon aortic valvuloplasty
Study Arms
  • Experimental: 1
    Cohort A: Sapien Valve
    Intervention: Device: Edwards SAPIEN Transcatheter Heart Valve
  • Active Comparator: 2
    Cohort A: other surgical valve
    Intervention: Device: Surgical Valve Replacement
  • Experimental: 3
    Cohort B: Sapien Valve
    Intervention: Device: Edwards SAPIEN Transcatheter Heart Valve
  • Active Comparator: 4
    Cohort B: Medical therapy
    Intervention: Other: medical management and/or balloon aortic valvuloplasty
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2017)
1057
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2007)
600
Actual Study Completion Date July 2017
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00530894
Other Study ID Numbers  ICMJE 2006-06-US
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Edwards Lifesciences
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP