Learn More THE APOLLO TRIAL


The APOLLO Trial is evaluating the safety and efficacy of the Intrepid™ transcatheter mitral valve replacement system for patients with severe mitral regurgitation. 
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CAUTION: Investigational device. Limited by United States law to investigational use. Exclusively for Clinical Investigations.

MITRAL REGURGITATION (MR)

  • MR affects an estimated 4 million people in the United States.1,2
  • 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 States 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.

TRIAL DESIGN

Diagram illustrating how the APOLLO clinical trial is designed.

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STUDY SYNOPSIS

Randomized Cohort and Single-arm Cohort

Primary Endpoint

  • The rate of all-cause mortality, disabling stroke, reoperation or reintervention, and cardiovascular hospitalization at one year
    • MAC Cohort: The rate of all-cause mortality and heart failure hospitalization at one year

Secondary Endpoint

  • Composite of all-cause mortality, disabling stroke, acute kidney injury, prolonged ventilation, deep wound infection, reoperation or reintervention, and major bleeding at 30 days or hospital discharge (whichever is longer)
  • Change in NYHA at 30 days
  • Quality of Life (QoL) improvements at 30 days (SF-12) and three months (KCCQ)
  • Echocardiographic assessments of degree of mitral valve regurgitation at one year
  • Cardiovascular hospitalization through one year

 

OVERVIEW OF THE INTREPID TMVR SYSTEM

Diagram of Intrepid Transcatheter Mitral Valve Replacement (TMVR) system showing location of outer stent, inner stent, and brim

The Intrepid transcatheter mitral valve replacement (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. It is designed to engage 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
  4. The Intrepid delivery system allows for recoverability at any point prior to full deployment.

FIND OUT IF YOUR PATIENTS ARE ELIGIBLE

Read through the inclusion/exclusion criteria and view more resources to help you determine if you have patients who are eligible to participate in the trial.

  

  

1

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

2

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