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Patient Eligibility THE APOLLO TRIAL


If you have patients with moderate to severe symptomatic mitral regurgitation, with or without 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.

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 mitral annular calcification (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

Key Exclusion Criteria

  • LVEF < 30%
  • End stage renal disease requiring chronic dialysis or creatinine clearance <45 cc/min within 30 days of the Index Procedure
  • 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 non-cardiac 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
For the full list of exclusion criteria, visit clinicaltrials.gov.

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

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