access-europe a two-phase observational study of the mitraclip® system in europe

Conditions: Mitral Valve (MV) Regurgitation

Summary: the mitraclip system enables the european physicians an alternative therapeutic option for patients with mitral regurgitation (mr). therapeutic alternatives are open-heart cardiac surgery, and palliative medical therapy with or without device therapy. the study will observe the outcomes of patients treated with the mitraclip system throughout 12-months as compared to the outcomes of patients treated by alternative therapies.

phase i: the primary objective of access-eu phase i is to gain information in the european union countries regarding the use of the mitraclip system with respect to health economics and clinical care. phase ii: (has been closed by sponsor) the primary objective of access-eu phase ii is to gather additional clinical data, specifically echocardiography core laboratory measurements of mr severity and left ventricular volumes and diameters, and other echocardiographic measures, on patients undergoing the mitraclip procedure in the european union countries, clinical data collected from both study phases, is expected to contribute to decision making with regards to mitraclip therapy selection in patients with mr: (a) by establishing the value of the mitraclip therapy in the continuum of care; and (b) by providing practical information that will allow physicians to make therapeutic decisions, assist hospitals to make purchasing decisions, and assist insurers in making coverage decisions. study design: access-europe is a two-phase prospective, observational, multicenter post-approval study of the mitraclip system for the treatment of mitral regurgitation (mr) in the european union countries. patients will be evaluated per standard practice at baseline, discharge, 6-months and 12-months. phase i of the study consists of patients who receive the mitraclip system for the treatment of mr and two concurrent comparator groups of (a) medically managed heart failure patients with mr and (b) patients who have undergone mitral valve surgery for mr. the two comparator groups will be followed and evaluated primarily from a health economic perspective. access eu study phase ii will consist of only patients who receive the mitraclip system, with the objective to collect additional clinical data, specifically echocardiography core laboratory evaluation of mr severity and other echocardiographic measures. enrollment of patients in each study phase is as follows: access-eu phase i: * a minimum of 300 mitraclip therapy group patients, * a minimum of 100 patients in the mitral valve surgery comparator group * as many patients as possible in the medical therapy comparator group first patient enrollment projection: q1, 2009 last patient enrollment projection: enrollment in the mitral valve surgery and medically therapy groups ceased on december 31, 2010. enrollment in the mitraclip group will cease when phase ii of the study is initiated at each site. access-eu phase ii: a minimum of 300 mitraclip therapy subjects will be enrolled in phase ii. first patient enrollment projection: q2, 2011 last patient enrollment projection: enrollment will cease when the sponsor has determined that an adequate number of patients have been enrolled.

Eligibility criteria:
inclusion criteria: * per the current approved labeling for the conformity european (ce) marked mitraclip system. exclusion criteria: * per the current approved labeling for the ce marked mitraclip system.

Keywords: mitral valve mitral regurgitation mitraclip mitral valve surgery mitral valve insufficiency or mitral regurgitation