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Heart FailureNCT00428467

Apical Compression Stitch - a New Option for LV Remodelling

A study testing LV Apex Compression in people with Heart Failure and Left Ventrikular Remodelling, run by Johann Wolfgang Goethe University Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
LV Apex Compression
Type of treatment
Surgery or procedure
How many people
Not given
Where
No sites listed yet
Study dates
May 2004to Apr 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Pacemaker
  • emergency Case,

About this study

Official title: Pronounced Apical Dilatation in Failing Left Ventricles - a New Option for Surgical Remodelling Techniques

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.

Read the 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.

Being tested
LV Apex Compression
Keywords
Heart Failure, LV Geometry, Heart MRT
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LV Apex CompressionProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2007 (estimated)
  2. Study startMay 2004
  3. Study completionApr 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00428467
Sponsor's protocol ID
Apex-stitch
Other IDs
236/04
Status last verified
Jan 2007
First submitted
29 Jan 2007
Last updated
30 Jan 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing LV Apex Compression in people with Heart Failure and Left Ventrikular Remodelling, run by Johann Wolfgang Goethe University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2007.

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