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The PARTNER II Trial: Placement of AoRTicTraNscathetER Valves Trial The Safety and Effectiveness of the SAPIEN XT™ Transcatheter Heart Valve with NovaFlex and Ascendra 2 delivery systems (Transfemoral and Transapical) in Intermediate Risk for Aortic Valve Surgery and Patients Who Cannot Undergo Surgery

Objective

The purpose of this investigational trial is to establish the safety and effectiveness of a new device and delivery systems in patients with aortic stenosis (narrowing of the aortic valve resulting in obstructed blood flow).

IRB Protocol Number
COMIRB 12-0660

All Other Trials

  • Heart & Circulation
Contact
Heather Maurer at 303-724-6473
Eligibility and Other Participant Information

Adults with severe, symptomatic aortic stenosis and would benefit from valve implantation may be eligible for the trial. In addition, adults with stenosed or insufficient bioprosthetic valve in any position may be eligible for the registry. Please contact the study coordinator for specific inclusion and exclusion criteria.