Clinical Trial: The Effect of the Hole in the Cardiac Septum Developed by the MitraClip Procedure on the Blood Flow Mechanics

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effect of the Iatrogenic Atrial Septal Defect After MitraClip Procedure on the Hemodynamic Outcome

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 Summary:

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.


Sponsor: RWTH Aachen University

Current Primary Outcome: change in hemodynamic parameters such as forward flow reduction through the mitral valve and left-to-right shunt due to the newly formed ASD [ Time Frame: after 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • quantitative change from baseline in the mitral regurgitation at 6 months [ Time Frame: after 6 months ]
    2D and 3D transthoracic echocardiography (TTE) with colour-Doppler techniques
  • quality of life [ Time Frame: after 6 months ]
    6 minutes walking test
  • change from baseline in the ASD area at 6 months [ Time Frame: after 6 months ]
    3D TEE (Transesophageal echocardiogram) by direct en face imaging


Original Secondary Outcome: Same as current

Information By: RWTH Aachen University

Dates:
Date Received: May 13, 2015
Date Started: July 2015
Date Completion: April 2017
Last Updated: April 5, 2016
Last Verified: April 2016