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Clinical Trials

Topic   Cardiology
Title   PARTNER 3: A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Requiring Aortic Valve Replacement Who Have Severe, Calcific, Symptomatic Aortic
Summary   The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients with severe, symptomatic aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR).
Description   Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 2% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.
IRB Number   16013
Inclusion/Notes  
  1. 65 years of age or older at time of consent.
  2. Symptomatic, severe, calcific aortic stenosis with the following TTE criteria:
    • Jet velocity = 4.0 m/s or mean gradient = 40 mmHg AND
    • AVA = 1.0 cm2 or AVA index = 0.6 cm2/m2
  3. Aortic valve annulus 273 mm2 - 683 mm2 measured by 3D imaging (CT, TEE or MRI)
  4. Adequate iliofemoral access with minimum average vessel diameter of 5.5mm (20, 23, 26mm) and 6.0mm (29mm) and acceptable level of vessel calcification and tortuosity for safe device implant
  5. NYHA Functional Class = II
  6. Heart team agrees the patient has a risk of operative mortality < 2% (e.g., STS <4).
  7. The study patient 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 site
Principal Name   Richard Schwartz, MD
Email   rschwartz@nyuwinthrop.org
Phone   516-663-2384
Alternate Phone   516-877-2626