For Healthcare Professionals - United States

CoreValve US Pivotal Trial High Risk Study

Redefining Optimal TAVR Outcomes at 2 Years

 

The CoreValve US Pivotal Trial applies clinical best practices—including CT-based sizing—and is meticulously monitored, including the use of an independent echocardiographic core lab. Within the trial, the High Risk Study randomized 795 patients between surgical aortic valve replacement (SAVR) and TAVR with the CoreValve System across 45 US sites. The study results continue to set the new standard in TAVR performance.

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Superior Survival at 2 Years

The CoreValve System demonstrates a low all-cause mortality rate that outperforms the standard of care at 2 years.

Superior Survival at 2 Years Chart

Lower Stroke Rate

The CoreValve system showed a lower rate of all stroke and a similar rate of major stroke vs. SAVR.

Lower Stroke Rate Chart

Superior Hemodynamics

Supra-annular design optimizes orifice area, delivering low single digit gradients that are superior to SAVR at each follow-up visit.

Superior Hemodynamics Chart

Low Rates of PVL

The CoreValve Nitinol frame conforms and seals to the annulus, maintaining a consistently low rate of moderate/severe PVL between 1 and 2 years.

Low Rates of PVL Chart


Source: Reardon, M, et al. A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis Deemed at Increased Risk for Surgery 2-Year Outcomes. Presented at ACC March 2015. San Diego, CA

Important Safety Information
Performance That Matters