Tendyne: Summit

STUDY IDENTIFIER:

Tendyne: Summit

CONDITION:

Severe Mitral Regurgitation

CONTACT INFO:

Sara Olson, RN   |   sara.olson@allina.com   |   612-863-7601

DESCRIPTION:

Prospective, controlled, multicenter clinical investigation with two trial arms: surgical and non-surgical. Subjects in the surgical arm will be randomized in a 2:1 ratio to the trial device or to conventional mitral valve surgery. Subjects in the non-surgical arm will receive the trial device.

CRITERIA LIST/ QUALIFICATIONS:

 
  1. Symptomatic, severe mitral regurgitation
  2. NYHA functional classification ≥ II (If Class IV, patient must be ambulatory)

INVESTIGATORS:

Paul Sorajja, MD

SPONSORS:

Abbott Vascular

STATUS:

Open/Enrolling