German Clinical Trials Register

Acronym/abbreviation of the study

Mitraclip Conductance

URL of the study

No Entry

Brief summary in lay language

The interventional therapy of MitraClip for the functional Mitral valve insufficiency (mitral valve insufficiency with impaired heart function) is an accepted method for patients with high surgery risk. There are only few data for patients with severe impairment of the left ventricular function (LVEF <25%). For this patients the peri- and postinterventional risk is higher than for patients with normal or slightly reduced LVEF and the longterme success for MI-reduction seem to be lower. Only few patients show a remodeling of the left ventricel due to reduction of the MI and left volume. That means that only for few patients there is a reduction of left diameters and show a higher ejection fraction (responder). The assumption is that non-responders have no recovery ability at the time of MitraClip-Therapy. For patients with severe reduced LVEF <25% and indication for MitraClip-Implantation we use a continous pressure-volume-analysis with conductance catheter during MitraClip-procedure for monitoring the heart function and hemodynamic. Additionaly, the pressure volume analysis quantifies the filling and pump properties of the impaired left ventricle. The objective of this study is a accurat systolic and diastolic functional analysis depending on the reduction of MI for patients with severe impaired heart function. We plan a correlation analysis with the clinical and morphlogical outcome post MitraClip-Procedure. This may help to find dependent and independent predictors for MitraClip-Theapy for responders and non-responders.

Brief summary in scientific language

Functional mitral regurgitation (MR) is common in patients with heart failure (HF) and depressed left ventricular (LV) ejection fraction. Nearly 25-30% of these patients develop a clinically relevant MR, which is associated with an adverse prognosis. Morbidity and mortality are directly related to MR severity (Rossi et al 2011). The goals of therapy in patients with secondary MR are to improve symptoms and quality of life, reduce heart failure hospitalizations, and potentially improve survival. The most recent European guidelines (2012) give a Class IIb C recommendation for MR repair for isolated severe secondary MR, but only for patients at low surgical risk with LVEF ≥ 30% (Vahanian et al 2012). Therefore, most HF patients with secondary MR do not undergo isolated MR surgery, especially in refractory severe systolic LV dysfunction. As a result, the lesser-invasive MitraClip® device has been developed to treat MR in surgically high risk patients. However, there are only two small studies examining Mitraclip® therapy in advanced systolic heart failure patients characterized by a EF ≤ 25% and a NYHA functional class ≥ III. These studies of Franzen (2011) and Auricchio (2011) suggest a similar procedural success as in patients with an ejection fraction higher than 25%, but the degree of LV remodeling was lower and the clinical non-responder rate (30-40% remains in NYHA III/IV) and hospital mortality were higher (5-6%). Our own clinical results have confirmed the higher clinical non-responder rate (40-50%) and perioperative mortality (4.4%) in advanced heart failure patients with an EF ≤ 25% and NYHA III/IV (n= 55). In 3 of these patients we observed a severe low output state and consecutive cardiogenic shock after successful MitraClip® procedure (MR ≤ 1). Therefore, especially in patients with advanced systolic heart failure, better predictors for a positive left ventricular performance and clinical response after significant MR reduction are needed. For the hemodynamic monitoring program during Mitraclip® procedure we used in our clinic the real time left atrial pressure (v wave) measurement in combination with continuous TEE. In cases of severe depressed left ventricular function (EF <25%, NYHA III/IV) we combined this procedure with an invasive real time left ventricular function analysis, made possible by continuous pressure–volume loop measurement (conductance catheter, CD Leycom). The objective is an exact Analysis of systolic and diastolic function in depending on reduction of mitral valve regurgitation. We plan to correlate these datas of the functional analysis with datas from clinical and morphological outcome post MitraClip Therapy. The goal is to improve the safety of the MitraClip® procedure via early recognition of signs of hemodynamic deterioration while performing the proceduren and to find Parameters for Response/Nonresponse after Mitraclip-Implantation.