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8110 Gatehouse Road, Falls Church, VA 22042

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

General Information

Age Group

Adult

Status

Active

Protocol Number

056-F275

Background Information

Mitral valvular disease, and specifically mitral valve regurgitation is the most common valve disease in the US. Currently mitral valve surgery (open heart surgery), either with repair or replacement, is the standard of care for patients with symptomatic mitral valve disease. Transcatheter mitral valve replacement (TMVR) is an emerging therapy that could offer patient a less invasive alternative to open heart surgery. The goal of the APOLLO trial is to evaluate whether TMVR is non-inferior to conventional mitral surgery with respect to composite endpoint rate of all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization at one year in patients with severe symptomatic native mitral regurgitation. The secondary objectives of this trial are to assess differences in quality of life, clinical benefit (efficacy endpoints) and health economics in patients with severe symptomatic native mitral regurgitation.

Study publication:
Early Experience With New Transcatheter Mitral Valve Replacement. Bapat V, Rajagopal V, Meduri C, Farivar RS, Walton A, Duffy SJ, Gooley R, Almeida A, Reardon MJ, Kleiman NS, Spargias K, Pattakos S, Ng MK, Wilson M, Adams DH, Leon M, Mack MJ, Chenoweth S, Sorajja P; Intrepid Global Pilot Study Investigators. J Am Coll Cardiol. 2018 Jan 2;71(1):12-21. doi: 10.1016/j.jacc.2017.10.061. Epub 2017 Nov 16.

Offered At

Inova Fairfax Hospital-Heart and Vascular Institute

3300 Gallows Road

Falls Church, VA 22042 

Principal Investigator

Shahram Yazdani, MD and Eric Sarin, MD

Eligibility Information

Subject has severe symptomatic mitral regurgitation and 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
  • Prior transcatheter mitral valve procedure with device currently implanted
  • Anatomic contraindications for IntrepidTM TMVR system (eg., annular dimensions, high risk of LVOT obstruction, transapical access, etc.)
  • Severe mitral annular calcification
  • Reduced ventricular function with left ventricular ejection fraction (LVEF) <25% Hemodynamic instability requiring either inotropic agents or mechanical circulatory support Need for emergent or urgent surgery