Table 1. MitraClip clinical trials and commercial use with corresponding number of patients (Data as of 11/30/2014, Abbott Vascular).
Study | Population | N* (n=18,505+95 surgery) |
---|---|---|
EVEREST I (feasibility) | Feasibility patients | 55 |
EVEREST II (pivotal) | Pre-randomized patients | 60 |
EVEREST II (pivotal) | Non-randomized patients (high risk study) | 78 |
EVEREST II (pivotal) | Randomized patients (2:1 clip to surgery) | 279: 184 Clip; 95 surgery |
REALISM (continued access) | Non-randomized patients | 899 |
Compassionate/emergency use | Non-randomized patients | 66 |
ACCESS Europe phase I | Non-randomized patients | 567 |
ACCESS Europe phase II | Non-randomized patients | 286 |
Commercial use | Commercial patients | 16,310 |
EVEREST II, Endovascular Valve Edge-to-Edge Repair Study II trial; TRAMI, transcatheter mitral valve interventions.