For Healthcare Professionals - United States

CoreValve US Pivotal Trial High Risk Study

Redefining Optimal TAVR Outcomes

Access the results:
Data Booklet
Abstract (NEJM)

 

The CoreValve US Pivotal Trial High Risk Study is a randomized, controlled trial comparing CoreValve transcatheter aortic valve replacement (TAVR) to surgical valve replacement in a high risk patient population. Leveraging clinical best practices, including CT-based sizing, and monitoring by independent core labs, trial investigators from 45 centers randomized 795 patients. The study results demonstrate how the CoreValve design delivers impressive performance on the outcomes that matter to physicians and to their patients.

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High Survival1

At one year, CoreValve TAVR significantly outperforms surgical valve replacement.

High Survival Chart

Low and Stable Stroke Rate1

Prospectively assessed, stroke rates are comparable to surgical valve replacement, due in part to the CoreValve self-expanding frame and low 18Fr delivery profile.

Low Stroke Rate Chart

Low Rate of Moderate/Severe Paravalvular Leak (PVL)1

With the CoreValve conforming frame and active radial force, the rate of moderate and severe PVL is low - 6.1% at one year.

Given direct access to the valve, paravalvular leak is rarely an issue in surgical valve replacement.

Low Rate of PVL Chart


Reference:

  1. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis [published online ahead of print March 29, 2014]. New Engl J Med 2014; doi:10.1056/NEJMoa1400590.

Important Safety Information
Performance That Matters