For Healthcare Professionals - United States

CoreValve US Pivotal Trial Extreme Risk Iliofemoral Study

Redefining Optimal TAVR Outcomes

Download the data booklet for full clinical information.

The Extreme Risk Iliofemoral Study of the CoreValve US Pivotal Trial is a prospective, controlled multicenter study of patients who are unable to undergo valve surgery.* Leveraging clinical best practices, including CT-based sizing, trial investigators treated 489 patients with the CoreValve transcatheter aortic valve.

High Survival

In a population in which two thirds of medically managed patients die by 2 years,1 63.5% of CoreValve extreme risk patients survive.

Corevalve Proof Chart - 2 Year Mortality

Low and Stable Stroke Rate

In addition to a low 1-year rate, only 0.9% of patients suffered a major stroke between 1 and 2 years.

Corevalve Proof Chart - 2 Year Major Stroke Landmark

Strong and Consistent Hemodynamic Performance

Supra-annular valve design optimizes orifice area, delivering low single-digit gradients out to two years.

Corevalve Proof Chart - Echocardio Findings

Maintained Improvement in PVL

The CoreValve Nitinol frame conforms and seals to the annulus, maintaining PVL improvements seen at one year.

Corevalve Proof Chart - Paravalvular Regurgitation

Stable Gains in Patient Functional Status

In a paired analysis, 92% of patients improved at least one class by two years, with 58% improving at least two classes.

Corevalve Proof Chart - TCT Loop NYHA Class

Low Rate of Major Vascular Complications2

The CoreValve device has a low rate of major vascular complications in patients with vasculature down to 6mm, largely due to its low 18Fr delivery profile.

Low Rate of Major Vascular Complications Chart


*Judged by a heart team, including a cardiac surgeon, these patients have a predicted risk of operative mortality and/or serious irreversible morbidity ≥50% at 30 days.

Data Presented at TCT 2014:

Yakubov SJ, et al. Long-term Outcomes Using a Self-Expanding Bioprosthesis in Patients with Severe Aortic Stenosis Deemed Extreme Risk for Surgery: Two-year Results from the CoreValve US Pivotal Trial. Presented at TCT September 2014. Washington D.C.

Reference:

  1. Leon MB, et al. Transcatheter aortic valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-1607.
  2. Popma JJ, et al. Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery, JACC 2014, doi: 10.1016/j.jacc.2014.02.556.

Important Safety Information
Performance That Matters