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

NCT ID: NCT02453451

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-04-30

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.

Conditions

Atrial Septal Defect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

2D-/3D-TTE; 3D-TEE, Walking Test

6 months after the MitraClip procedure

Group Type: EXPERIMENTAL

2D-/3D-TTE

Intervention Type: OTHER

recording of 3 cardiac cycles

3D-TEE

Intervention Type: OTHER

with colour-Doppler techniques for recording the ASD and the mitral valve

Walking Test

Intervention Type: OTHER

for 6 minutes

MitraClip procedure

Intervention Type: PROCEDURE

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

Interventions

2D-/3D-TTE

recording of 3 cardiac cycles

Intervention Type: OTHER

3D-TEE

with colour-Doppler techniques for recording the ASD and the mitral valve

Intervention Type: OTHER

Walking Test

for 6 minutes

Intervention Type: OTHER

MitraClip procedure

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

Intervention Type: PROCEDURE

Other Intervention Names

2-/3-dimensional transthoracic echocardiography; 3-dimensional transesophageal echocardiogram

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital RWTH Aachen, Department of Medical Clinic I

Aachen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Mohammad Almalla

Role: CONTACT

malmalla@ukaachen.de

+49 241 80 36771

Other Identifiers

15-016

Identifier Type: -

Identifier Source: org_study_id