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Apical Compression Stitch - a New Option for LV Remodelling

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00428467
First Posted: January 30, 2007
Last Update Posted: January 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johann Wolfgang Goethe University Hospital
  Purpose
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.

Condition Intervention
Heart Failure Left Ventrikular Remodelling Left Ventricular Geometry Procedure: LV Apex Compression

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Pronounced Apical Dilatation in Failing Left Ventricles – a New Option for Surgical Remodelling Techniques

Further study details as provided by Johann Wolfgang Goethe University Hospital:

Study Start Date: May 2004
Estimated Study Completion Date: April 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pacemaker
  • emergency Case,
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428467


Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Omer Dzemali, MD Dept. of Thoracic and Cardiovascular Surgery, J.W. Goethe University, Frankfurt am Main, Germany
  More Information

ClinicalTrials.gov Identifier: NCT00428467     History of Changes
Other Study ID Numbers: Apex-stitch
236/04
First Submitted: January 29, 2007
First Posted: January 30, 2007
Last Update Posted: January 30, 2007
Last Verified: January 2007

Keywords provided by Johann Wolfgang Goethe University Hospital:
Heart Failure
LV Geometry
Heart MRT

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases