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PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk
Trial ID: NCT01314313
The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.
Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients
D. Craig Miller, M.D.
Thelma and Henry Doelger Professor of Cardiovascular Surgery, Emeritus
Alan Yeung, MD
Li Ka Shing Professor in Cardiology
Rajesh Dash, MD PhD; Director of SSATHI & CardioClick
Associate Professor of Medicine (Cardiovascular Medicine)
1. Patient has senile degenerative aortic valve stenosis with echocardiographically
derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s and an
initial aortic valve area (AVA) of ≤0.8 cm2 or indexed EOA < 0.5 cm2/m2 Qualifying
echo must be within 60 days of the date of the procedure.
2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA
Functional Class II or greater.
3. The heart team agrees (and verified in the case review process) that valve
implantation will likely benefit the patient.
4. The study patient or the study patient'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 Institutional Review Board (IRB) of the respective clinical
5. The study patient agrees to comply with all required post-procedure follow-up visits
including annual visits through 5 years and analysis close date visits, which will be
conducted as a phone follow-up.
6. Study patient agrees to undergo surgical aortic valve replacement (SAVR) - if
randomized to control treatment.
1. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended
treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥
twice normal in the presence of MB elevation and/or troponin level elevation (WHO
2. Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is
3. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant
aortic regurgitation >3+).
4. Preexisting mechanical or bioprosthetic valve in any position (except NR3).
5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is
performed within 30 days of the index procedure (unless part of planned strategy for
treatment of concomitant coronary artery disease). Implantation of a permanent
pacemaker or ICD (S3 Cohort only) is not excluded.
6. Heart team assessment of inoperability (including examining cardiac surgeon).
device: TAVR Implantation with SAPIEN XT
device: SAVR Implantation
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Martina Kelly Speight