CAUTION: Investigational device. Limited by United States law to investigational use. Exclusively for Clinical Investigations.

Learn about the TMVR procedure

APOLLO TRIAL  

As part of our commitment to developing solutions for the treatment of valve disease, Medtronic is sponsoring the landmark APOLLO Trial. APOLLO will evaluate transcatheter mitral valve replacement (TMVR) — a therapy designed to correct mitral regurgitation.


MITRAL REGURGITATION (MR)

  • MR affects an estimated four million people in the United States1,2
  • Mitral valve leaflets become damaged or stretched out where they don’t close properly, which allows blood to flow backward causing MR
  • Prior heart attacks and heart disease increases the risk of developing of MR
  • If left untreated, MR may lead to chronic heart failure (HF), the leading cause of hospitalization in the United State and Europe
    • Approximately 50% of HF patients will die within five years
    • Approximately 10% of HF patients have symptoms, such as shortness of breath at rest

OVERVIEW OF THE INTREPID TMVR SYSTEM

The Intrepid TMVR system integrates self-expanding stent technology with a tissue heart valve to facilitate minimally invasive, catheter-based implantation.

The prosthesis is compressed inside a hollow delivery catheter and implantation is completed through trans-apical access. The prosthesis is designed to attach and conform to the native annulus without need for additional sutures, tethers, or anchors.

The device design features:

  1. A conformable Outer Stent designed to engage the annulus and leaflets, providing fixation while isolating the inner stent from the dynamic anatomy
  2. A flexible Brim designed to aid imaging during implantation and subsequent tissue in-growth
  3. The circular Inner Stent houses a 27 mm tri-leaflet bovine pericardium valve
Intrepid TMVR Trial Device Detail

TRIAL DESIGN

Apollo Trial Design

STUDY SYNOPSIS

  Randomized Cohort Single-arm Cohort
Primary Endpoint
  • The rate of all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization at one year
Secondary Endpoint
  • Composite of all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation (or reintervention) for any reason and major bleeding at 30 days or hospital discharge whichever is longer
  • Change in NYHA at one year
  • Quality of Life (QoL) Improvements at 30 days (SF-12) and one year (KCCQ)
  • Echocardiographic assessments of degree of mitral valve regurgitation at one year
  • Days alive out of hospital at one year (all hospitalizations) from index procedure
  • Cardiovascular hospitalization through one year
Follow-up Evaluations
  • 30 days, three months, six months, and annually starting one through five years

Eligibility

The following table outlines inclusion and exclusion criteria for the Apollo trial.

  Randomized Cohort Single-arm Cohort
Key Inclusion Criteria
  • Subject has severe symptomatic mitral regurgitation
  • Heart team agrees the patient is a candidate for bioprosthetic mitral valve replacement
Key Exclusion Criteria
  • Prior transcatheter mitral valve procedure with device currently implanted
  • Anatomic contraindications for the Intrepid TMVR system
    (e.g., annular dimensions, high risk of LVOT obstruction, transapical access, etc.)
  • Prohibitive 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

1

U.S. Census Bureau. Statistical Abstract of the U.S.: 2006, Table 12.

2

Nkomo VT, et al. Lancet. 2006;368:1005-1011.