THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
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.
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.
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.