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.
Superior Survival at 2 Years
The CoreValve System demonstrates a low all-cause mortality rate that outperforms the standard of care at 2 years.
Lower Stroke Rate
The CoreValve system showed a lower rate of all stroke and a similar rate of major stroke vs. SAVR.
Supra-annular design optimizes orifice area, delivering low single digit gradients that are superior to SAVR at each follow-up visit.
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.
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