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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00530894
First Posted: September 18, 2007
Last Update Posted: September 13, 2017
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.
Information provided by (Responsible Party):
Edwards Lifesciences
  Purpose
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 Intervention
Critical Aortic Stenosis Device: Edwards SAPIEN Transcatheter Heart Valve Device: Surgical Valve Replacement Other: medical management and/or balloon aortic valvuloplasty

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Edwards Lifesciences:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 1057
Actual Study Start Date: April 2007
Study Completion Date: July 2017
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
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


  Show 26 Study Locations
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT00530894     History of Changes
Other Study ID Numbers: 2006-06-US
First Submitted: September 14, 2007
First Posted: September 18, 2007
Results First Submitted: March 7, 2016
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:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction