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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02453451
Other study ID # 15-016
Secondary ID
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


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
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