Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT02453451
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT02453451
Study Brief:
Protocol Section:
NCT02453451