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

Atrial Septal Defect Clinical Trial

— MitraClipASD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02453451
• Other study ID #: 15-016
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2015
• Last updated: April 5, 2016
• Start date: July 2015
• Est. completion date: April 2017

Study information

• Verified date: April 2016
• Source: RWTH Aachen University
• Contact: Mohammad Almalla
• Phone: +49 241 80 36771
• Email: malmalla[@]ukaachen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients in which a percutaneous mitral valve reconstruction via the MitraClip system shall be performed due to severe mitral insufficiency because a conventional surgery would be too stressful for them

• legal age (=18 years)

• written informed consent prior to study participation

• subjects who are contractually capable and mentally able to understand and follow the instructions of the study personnel

Exclusion Criteria:

• malignant diseases

• varicose veins of the esophagus

• patients with central nervous system dysfunction

• pregnant and lactating females

• subject has been committed to an institution by legal or regulatory order

• dependency or working relationship with the investigator

• participation in a parallel interventional clinical study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Atrial Septal Defect
• Heart Septal Defects
• Heart Septal Defects, Atrial

Intervention

Other:
• 2D-/3D-TTE
recording of 3 cardiac cycles
• 3D-TEE
with colour-Doppler techniques for recording the ASD and the mitral valve
• Walking Test
for 6 minutes

Procedure:
• MitraClip procedure
catheter-based non-surgical procedure in which the atrioventricular valves were stuck together permanently via a clip (during the regular patient care)

Locations

Country	Name	City	State
Germany	University Hospital RWTH Aachen, Department of Medical Clinic I	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in hemodynamic parameters such as forward flow reduction through the mitral valve and left-to-right shunt due to the newly formed ASD		after 6 months	No
Secondary	quantitative change from baseline in the mitral regurgitation at 6 months	2D and 3D transthoracic echocardiography (TTE) with colour-Doppler techniques	after 6 months	No
Secondary	quality of life	6 minutes walking test	after 6 months	No
Secondary	change from baseline in the ASD area at 6 months	3D TEE (Transesophageal echocardiogram) by direct en face imaging	after 6 months	No