THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Critical Aortic Stenosis

Intervention / Treatment
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* Device: Edwards SAPIEN Transcatheter Heart Valve
* Device: Surgical Valve Replacement
* Other: medical management and/or balloon aortic valvuloplasty


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Death from any cause. | 1 Year | 
| Composite of Death and Recurrence Hospitalization. | 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 | 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) | Number of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure | 1 year | 
| 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. | 1 year | 
| 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. | Baseline and 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Valvular Heart Disease, Critical/Severe Aortic Stenosis, High risk symptomatic patients