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

Sponsor
RWTH Aachen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02453451
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
21
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 2D-/3D-TTE
  • Other: 3D-TEE
  • Other: Walking Test
  • Procedure: MitraClip procedure
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Effect of the Iatrogenic Atrial Septal Defect After MitraClip Procedure on the Hemodynamic Outcome
Study Start Date :
Jul 1, 2015
Anticipated Primary Completion Date :
Jan 1, 2017
Anticipated Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 2D-/3D-TTE; 3D-TEE, Walking Test

6 months after the MitraClip procedure

Other: 2D-/3D-TTE
recording of 3 cardiac cycles
Other Names:
  • 2-/3-dimensional transthoracic echocardiography

    • Other: 3D-TEE
    with colour-Doppler techniques for recording the ASD and the mitral valve
    Other Names:
  • 3-dimensional transesophageal echocardiogram

    • Other: 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)

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Secondary Outcome Measures

    1. quantitative change from baseline in the mitral regurgitation at 6 months [after 6 months]

      2D and 3D transthoracic echocardiography (TTE) with colour-Doppler techniques

    2. quality of life [after 6 months]

      6 minutes walking test

    3. change from baseline in the ASD area at 6 months [after 6 months]

      3D TEE (Transesophageal echocardiogram) by direct en face imaging

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital RWTH Aachen, Department of Medical Clinic I Aachen Germany 52074

    Sponsors and Collaborators

    • RWTH Aachen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RWTH Aachen University
    ClinicalTrials.gov Identifier:
    NCT02453451
    Other Study ID Numbers:
    • 15-016
    First Posted:
    May 25, 2015
    Last Update Posted:
    Apr 6, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by RWTH Aachen University
    MitraClip
    atrial septal defect
    iatrogenic
    Additional relevant MeSH terms:
    Heart Septal Defects
    Heart Septal Defects, Atrial

    Study Results

    No Results Posted as of Apr 6, 2016