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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Critical Aortic Stenosis Device: Edwards SAPIEN Transcatheter Heart Valve Device: Surgical Valve Replacement Other: medical management and/or balloon aortic valvuloplasty Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1057 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve
Actual Study Start Date : April 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Death [ Time Frame: 1 Year ]
    Death from any cause.

  2. Composite of Death and Recurrence Hospitalization. [ Time Frame: duration of study ]
    Death from any cause or repeat hospitalization after intervention.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.



Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530894


Locations
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Sponsors and Collaborators
Edwards Lifesciences
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT00530894    
Other Study ID Numbers: 2006-06-US
First Posted: September 18, 2007    Key Record Dates
Results First Posted: May 11, 2017
Last Update Posted: September 13, 2017
Last Verified: August 2017
Keywords provided by Edwards Lifesciences:
Valvular Heart Disease
Critical/Severe Aortic Stenosis
High risk symptomatic patients
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction