Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve (TRANSFORM™)

Multi-CenTer Experience With the Rapid Deployment EDWARDS INTUITY Valve System FOR Aortic Valve ReplaceMent

The purpose of the clinical study is to prove that the heart valve device is safe, effective, and performs as intended.

Are you Eligible? (Inclusion Criteria)

Subjects will be required to meet all inclusion criteria:

  • Male or female, age 18 years or older
  • Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replace-ment as indicated in the preoperative evaluation
  • Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery
  • Provide written informed consent
  • Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up

Specialty Area(s)