Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO)

General Information

Age Group

Adults

Status

Recruiting

Protocol Number

056-F275

Background Information

Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation who are candidates for conventional mitral valve surgery.

Offered At

Inova Fairfax Hospital
3300 Gallows Road
Falls Church, VA 22042
Principal Investigator

Shahram Yazdani, MD

Eric Sarin, MD

Eligibility Information

  • Subject has moderate to severe or severe symptomatic mitral regurgitation
  • Heart Team agrees that patient is a candidate for bioprosthetic mitral valve replacement

Ineligibility Information

  • Subject has comorbidities such that the Heart Team agrees predicted risk of operative mortality is < 3% at 30 days or has ≥ 35% risk of mortality or irreversible major morbidity at 30 days
  • Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
  • Subject with mitral anatomy that would preclude management of the sub-valvular apparatus and/or full chordal sparing
  • Prior mitral valve surgery including previously implanted mitral valve, ring, or band