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

April 5, 2016 updated by: RWTH Aachen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • University Hospital RWTH Aachen, Department of Medical Clinic I
        • Principal Investigator:
          • Mohammad Almalla
        • Sub-Investigator:
          • Sebastian Reith, Dr. med.
        • Sub-Investigator:
          • Ertunc Altiok, PD Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after 6 months
quality of life
Time Frame: after 6 months
6 minutes walking test
after 6 months
change from baseline in the ASD area at 6 months
Time Frame: after 6 months
3D TEE (Transesophageal echocardiogram) by direct en face imaging
after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 25, 2015

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Septal Defect

Clinical Trials on 2D-/3D-TTE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe