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. 2015 Sep;7(9):1509–1517. doi: 10.3978/j.issn.2072-1439.2015.07.38

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.