Low Risk “CAP”

STUDY IDENTIFIER:

Low Risk “CAP”

CONDITION:

Aortic Valve Stenosis

CONTACT INFO:

Aisha Ahmed   |   aisha.ahmed@allina.com   |   612-863-3974

DESCRIPTION:

The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

CRITERIA LIST/ QUALIFICATIONS:

 
  1. Symptomatic or asymptomatic severe aortic stenosis
  2. Considered low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days.

INVESTIGATORS:

Mario Goessl, MD

SPONSORS:

Medtronic

STATUS:

Open/Enrolling