CoreValve US Pivotal Trial High Risk Study
The CoreValve US Pivotal Trial applies clinical best practices—including CT-based sizing—and is meticulously monitored, including adjudication of pertinent adverse events by a Clinical Events Committee (CEC). Within the trial, the High Risk Study randomized 795 patients between surgical aortic valve replacement (SAVR) and TAVI with the CoreValve System across 45 US sites. The study results continue to set a standard in TAVR performance.
Superior Long-Term Clinical Outcomes
Lower Rate of Mortality or Stroke with CoreValve than with SAVR.
Unsurpassed Hemodynamic Performance
Supra-annular design optimizes orifice area, delivering low single digit gradients that are superior to SAVR at each follow-up visit.
CoreValve had significantly better valve performance over SAVR at all follow-up visits (P<0.001)
Source: Deeb, G. et al. 3-Year Results From the CoreValve US Pivotal High Risk Randomized Trial Comparing Self-expanding Transcatheter and Surgical Aortic Valves. Presented at ACC April 2016. Chicago, IL.