HVP_Apollo Mitral

HVP Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation (APOLLO)

Multi-center, global, prospective, randomized, interventional, pre-market trial with two subject groups: the randomized group will be randomized on 1:1 basis to either the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the study device.

Key Inclusion Criteria:

1. Moderate to severe or severe symptomatic mitral regurgitation
candidate for bioprosthetic mitral valve replacement, as determined by heart team

Exclusion Criteria:

1. Prior transcatheter mitral valve procedure with device currently implanted
anatomic contraindications
2. Prohibitive mitral annular calcification
3. Left ventricular ejection fraction <25%
4. Need for emergent or urgent surgery
5. Hemodynamic instability

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
IDE
NCT03242642
Heart and Vascular
Valvular Heart Disease, Heart Failure
Ethan Korngold MD
Medtronic
Angela Redd
  • Providence St. Vincent Medical Center