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Apical Compression Stitch - a New Option for LV Remodelling

Primary Purpose

Heart Failure, Left Ventrikular Remodelling, Left Ventricular Geometry

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LV Apex Compression
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, LV Geometry, Heart MRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Gender
  • Coronary Disease
  • impaired LF Function (EF<35%)

Exclusion Criteria:

  • Pacemaker
  • emergency Case,

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 29, 2007
    Last Updated
    January 29, 2007
    Sponsor
    Johann Wolfgang Goethe University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00428467
    Brief Title
    Apical Compression Stitch - a New Option for LV Remodelling
    Official Title
    Pronounced Apical Dilatation in Failing Left Ventricles - a New Option for Surgical Remodelling Techniques
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2007
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2007 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johann Wolfgang Goethe University Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    The current study analyses the LV geometry of failing LVs measured by MRI scanning with respect to systolic versus diastolic function. A new surgical method for remodelling enlarged left ventricles is introduced.An apical remodelling stitch led to significant remodelling which was accompanied by improvement in ventricular function.
    Detailed Description
    Heart failure is a common disease and remains a growing cause of morbidity and mortality worldwide. The poor prognosis of dietetic and medical treatment has led to Increasing interest in interventional and surgical techniques for improvement of LV function. Besides heart transplantation surgical interventions in heart failure patients focussed on mitral valve repair, biventricular stimulation and correction of coronary artery disease. A partial ventriculectomy as a true remodelling procedure has been invented by Battista with varying clinical results and reported high mortalities up to 20%. More commonly used is the Dor procedure , which is applicable for anterior wall aneurysms and has excellent short and long term results. On the other hand it has been designed for chronic aneurysms and is not suitable for dilated cardiomyopathies or subacute infarctions. More recently medical devices like the Acorn™ net or the Myosplint™ have been invented. Both require implantation of significant foreign material and are combined with inherent disadvantages. The Acorn™ device prevents progressive dilatation, but does not support systolic ventricular function, whereas the Myospilnt™ creates a less spherical geometry but not a physiological shape of the left ventricle (LV). Detailed knowledge of the underlying geometrical changes in failing left ventricles is a prerequisite to achieve improvement in function by surgery . It has been described that with progressive heart failure, the oval form changes towards a more spherical geometry. To classify the shape and amount of deformation, several indices have been defined . The classical sphericity index (SI) as the ratio between the short and long axis is commonly used and is able to predict volume increases e.g. after myocardial infarctions . Furthermore, it has been used for evaluation of remodelling surgery and mitral valve repair in heart failure patients . This index serves well for an overall judgement of the left ventricular geometry, but does not pay attention to asymmetrical aspects of remodelling in heart failure, which is present e.g. after myocardial infarctions. Especially the apex is not considered sufficiently, although it can be reshaped ideally in procedures like the Dor operation . Therefore a focus on this region of the left ventricle is desirable from a surgical point of view. Cine MRI scanning of the heart has gained increasing acceptance in the diagnosis of ventricular geometry changes , as it is highly accurate in determining global myocardial function without using ionising radiation or assumptions of ventricular shape , which are major drawbacks of other imaging modalities such as nuclear ventriculography or echocardiography , respectively. The current study analyses the LV geometry of failing LVs measured by MRI scanning with respect to systolic versus diastolic function. A new surgical method for remodelling enlarged left ventricles is introduced.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Left Ventrikular Remodelling, Left Ventricular Geometry
    Keywords
    Heart Failure, LV Geometry, Heart MRT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    LV Apex Compression

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Gender Coronary Disease impaired LF Function (EF<35%) Exclusion Criteria: Pacemaker emergency Case,
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Omer Dzemali, MD
    Organizational Affiliation
    Dept. of Thoracic and Cardiovascular Surgery, J.W. Goethe University, Frankfurt am Main, Germany
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Apical Compression Stitch - a New Option for LV Remodelling

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