Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement

What we are studying

The purpose of this research study is to obtain data on the safety and effectiveness of the CoreValve System and Evolut R System on patients considered low risk for SAVR. The Corevalve System and Evolut R System have been approved by the US Food and Drug Administration (FDA) for patients considered to be extreme or high risk for open heart surgery, but it has not been approved for patients considered to be low risk for open heart surgery. Therefore, the CoreValve System and Evolut R System are considered “investigational devices” in this low risk patient population. This means that research studies are required to determine if they are safe, and provide clinical benefit. Data from this study will be used to support regulatory submissions to obtain commercial approval for the CoreValve System and Evolut R System in low risk patients.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Aortic stenosis

What is involved

  • Randomized SAVR vs TAVR
  • 6 echocardiograms
  • 4 ecgs
  • 8 questionnaires.

Compensation

Compensation for time and travel for follow-up visits.

Contact Information

Study Coordinator
Amanda Morgan
Email
[email protected]
Phone
-4432
Principal Investigator
Dr. David Zhao

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.