The APOLLO Trial

Patient eligibility

If you have patients with moderate to severe symptomatic mitral regurgitation, with or without mitral annular calcification (MAC), they may be candidates for this 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.

CAUTION: Investigational device. To be used by qualified investigators only. Exclusively for clinical investigations.

Eligibility

The following outlines inclusion and exclusion criteria for the APOLLO Trial.

Key inclusion criteria

  • Subject has moderate-to-severe or severe symptomatic mitral regurgitation — or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC (for the MAC cohort only).
  • Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for approved transcatheter repair and surgical mitral valve intervention.
  • Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
  • Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
Decorative element

Key exclusion criteria

  • LVEF < 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 to < 30% will be further evaluated (RVD, pulmonary HTN, and left ventricular function) by the APOLLO screening committee for approval.
  • End-stage renal disease requiring chronic dialysis or creatinine clearance < 30 cc/min
  • Severe chronic obstructive pulmonary disease (COPD) 
  • Significantly impaired right ventricular function in the presence of moderate or greater tricuspid regurgitation
  • Significant frailty (assessed by a combination of age, BMI, Albumin, Katz Index & Essential Frailty Toolset score)
  • Estimated life expectancy of < 24 months due to associated noncardiac comorbid conditions
  • Currently implanted mitral valve or prior transcatheter mitral valve procedure with device currently implanted
  • Hemodynamic instability requiring either dependency on inotropic agents or mechanical circulatory support
Decorative element

Find a study location near you. 

See the directory of all clinical trial locations participating in the APOLLO Trial.

See clinical trial locations