This will play a video - Illustration of the Intrepid transcatheter mitral valve during TMVR procedure

Learn more The Apollo Trial

CAUTION: The Intrepid™ Transcatheter Mitral Valve Replacement System is an investigational device. Limited by federal (United States) law to investigational use. Exclusively for clinical investigations. Not approved by FDA and not for sale in the United States.

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 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. 

Mitral Annular Calcification (MAC)

  • MAC is a chronic degenerative process of the mitral valve that has been found to increase the incidence of mitral valve disease and arrhythmias and influence the outcomes of cardiac surgery3
  • Mitral Annular Calcification (MAC) is estimated to affect approximately 9% of Americans4 and reaches about 42% in elderly patients who suffer from cardiovascular disease5
  • Presence of MAC is associated with a significant increased risk of cardiovascular death and all-cause death, compared to patients without MAC6 
  • Severe MAC presents significant technical challenges during surgical mitral valve repair or replacement7 and presence of MAC, regardless of severity, is independently associated with increased operative mortality and adverse postoperative outcomes in patients undergoing surgical mitral valve replacement8  

Trial design

Diagram illustrating how the APOLLO clinical trial is designed

Study synopsis

Primary Cohort and MAC

Primary Endpoint

  • Primary Cohort: The rate of all-cause mortality, or heart failure hospitalization post 30-days, or KCCQ improvement < 10 as evaluated at 1 year
  • MAC Cohort: The rate of all-cause mortality or heart failure hospitalization at 1 year

Secondary Endpoint

  • Composite of all-cause mortality, disabling stroke, acute kidney injury (stage 3 or with renal replacement), prolonged ventilation, deep wound infection, reoperation or reintervention, or ≥ major bleeding at 30 days or at hospital discharge whichever is longer
  • Change in NYHA at 30 days
  • Change in Quality of Life (QoL) at 30 days (SF-12) 
  • Change in Quality of Life (QoL) at 3 months as assessed by KCCQ
  • Degree of mitral regurgitation at 1 year as assessed by Echo Core Lab
  • Cardiovascular hospitalization through 1 year

 

Overview of the Intrepid TMVR system

Diagram of the Intrepid TMVR system with numbered callouts showing the location of outer stent, inner stent, and brim

The Intrepid Transcatheter Mitral Valve Replacement System (TMVR) 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 either transapical (TA) or transfemoral (TF) 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.

See eligibility criteria

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1

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

2

Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet. September 16, 2006;368(9540):1005-1011.

3

Abramowitz Y, Jilaihawa H, Chakravarty T, Mack MJ, Makkar RR. Mitral Annulus Calcification. J Am Coll Cardiol. October 27, 2015;66(17):1934-1941.

4

Vergeer M, Cohn DM, Boekholdt SM, et al. Lack of association between common genetic variation in endothelial lipase (LIPG) and the risk for CAD and DVT. Atherosclerosis. August 2010;211(2):558-564.

5

Barasch E, Gottdiener JS, Marino Larsen EK, Chaves PHM, Newman AB, Manolio TA. Clinical significance of calcification of the fibrous skeleton of the heart and aortosclerosis in community dwelling elderly. The Cardiovascular Health Study (CHS). Am Heart J. January 2006;151(1):39-47.

6

Fox CS, Vasan RS, Parise H, et al. Mitral annular calcification predicts cardiovascular morbidity and mortality: the Framingham Heart Study. Circulation. March 25, 2003;107(11):1492-1506.

7

Bedeir K, Kaneko T, Aranki S. Current and evolving strategies in the management of severe mitral annular calcification. J Thorac Cardiovasc Surg. February 2019;157(2):555-566.

8

Kaneko T, Hirji S, Percy E, et al. Characterizing Risks Associated With Mitral Annular Calcification in Mitral Valve Replacement. Ann Thorac Surg. December 2019;108(6):1761-1767.