Twelve Intrepid

STUDY IDENTIFIER:

Twelve Intrepid

CONDITION:

Mitral Valve Insufficiency

CONTACT INFO:

Kate Jappe   |   Kate.jappe@allina.com   |   612-863-7347

DESCRIPTION:

Non-randomized pilot study to evaluate the safety and performance of the investigational Medtronic Twelve Intrepid TMVR System in high risk patients with severe, symptomatic mitral regurgitation.

CRITERIA LIST/ QUALIFICATIONS:

  • Severe mitral regurgitation (MR Grade 3-4+).
  • Symptomatic mitral regurgitation (NYHA Class II-IV).
  • Trans-apical access deemed feasible by the treating physician.
  • Native mitral valve geometry and size compatible with the Twelve TMVR.

INVESTIGATORS:

Paul Sorajja, MD

SPONSORS:

Twelve, Inc.

STATUS:

Open/Enrolling