PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

Not Recruiting

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.

Official Title

Edwards SAPIEN XT Transcatheter Heart Valve Therapy for Intermediate and High Risk Patients

Stanford Investigator(s)

Rajesh Dash, MD PhD;      Director of SSATHI & CardioClick
Rajesh Dash, MD PhD; Director of SSATHI & CardioClick

Associate Professor of Medicine (Cardiovascular Medicine)

Alan Yeung, MD
Alan Yeung, MD

Li Ka Shing Professor in Cardiology


Inclusion Criteria

   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.

Exclusion Criteria

   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

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Martina Kelly Speight