Atrial Septal Defect Clinical Trial
Official title:
The Effect of the Iatrogenic Atrial Septal Defect After MitraClip Procedure on the Hemodynamic Outcome
Patients received a MitraClip procedure because of a leakiness of their mitral valves. During this procedure the atrioventricular valves were stuck together permanently via a clip which leads to a reduction of leakiness. As a result of this procedure a small hole remains at the cardiac septum which is called an atrial septal defect (ASD). In most cases the hole will close after a few weeks or months, but in many other cases not. Until now there is no exact data about the effect of this hole on the filling pressure in the heart or on the blood flow behaviour. So the aim of this study is a precise analysis of the blood flow mechanics during and after the MitraClip procedure to identify criteria to get more informations for a better strategy and regulation of the MitraClip procedure.
The percutaneous mitral valve reconstruction (PMVR) using the MitraClip system has become an
established therapeutic alternative for patients with symptomatic mitral regurgitation and
high operative risk. The MitraClip technology represent a catheter-based non-surgical
procedure in which a metal cramp (clip) is transported to the place of the defective mitral
valve. At the same time, it occurs also a 3-dimensional transesophageal echocardiogram
(3D-TEE) with a transseptal puncture to control this procedure. After removal of the guiding
catheter a new atrial septal defect can develop which can close spontaneously after weeks or
months.
In this study criteria for a standardized evaluation about the effect of the new ASD on
hemodynamic parameters - before and after the MitraClip procedure - shall be validated for
the first time. The investigators expect to obtain new findings through the exact analysis
of the newly formed ASD for the planning, regulation and follow-up of the mitral
insufficiency treatment.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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