APOLLO Trial: Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation
Protocol Description
Medtronic Intrepid™ TMVR System is intended for use in patients with moderate-to-severe or severe symptomatic mitral regurgitation who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
Eligibility Criteria
Inclusion Criteria
- Moderate-to-severe or severe symptomatic mitral regurgitation OR moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of mitral annular calcification (MAC; for the MAC cohort only)
- Unsuitability for transcatheter repair or surgical mitral valve intervention as agreed upon by the local site multidisciplinary heart team experienced in mitral valve therapies
Exclusion Criteria
- Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction
- Currently implanted mitral valve
- Prior transcatheter mitral valve procedure with device currently implanted
- Anatomic contraindications for Intrepid™ TMVR Systems (e.g., annular dimensions, high risk of LVOT obstruction, system access, etc.)
- Anatomically prohibitive mitral annular calcification (MAC)
- Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
- Severe tricuspid regurgitation
- Moderate or greater tricuspid regurgitation with echocardiographic evidence of significantly impaired right ventricular function as assessed by the echo core lab
- Evidence of new or untreated intracardiac mass or thrombus
Principal Investigator
Jason Foerst, MD, is the medical director of the Structural Heart and Valve Center at Carilion Clinic and an assistant professor of Medicine at the Virginia Tech Carilion School of Medicine.
