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Pilot Study for Evaluation of Left Ventricular Assist Device in Heart Failure for Non Cardiac Transplant Candidates and Non Responders to Resynchronization

2014-07-23 21:09:01 | BioPortfolio

Summary

Prevalence of heart failure is growing up. To the advanced stages of the disease, prognosis is bleak with high mortality rate.Cardiac resynchronization has been developped in order to respond to this issue but one third of patients are considering as non responders. For this patients, also non candidates for heart transplant, mechanical circulatory support could represent an alternative to an optimal medical treatment.

However, no randomised clinical trial has proved it yet. Morever, conditions of the feasibilty (in real conditions)of such a trial in Europe and the acceptance of randomisation by the focused patients are not well knowed.

The objectives of this pilot randomised trial are to argue feasibility and acceptance, also to update efficacity and quality of life data by comparing results betweew "heartmate II left ventricular assist device group" and control (optimal medical treatment) group.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Heart Failure at NYHA Satge III or IV

Intervention

heart mate II

Location

University Hospital
Rennes
France

Status

Recruiting

Source

Rennes University Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:01-0400

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Medical and Biotech [MESH] Definitions

A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.

Enlargement of the HEART, usually indicated by a cardiothoracic ratio above 0.50. Heart enlargement may involve the right, the left, or both HEART VENTRICLES or HEART ATRIA. Cardiomegaly is a nonspecific symptom seen in patients with chronic systolic heart failure (HEART FAILURE) or several forms of CARDIOMYOPATHIES.

Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE).

Heart failure caused by abnormal myocardial contraction during SYSTOLE leading to defective cardiac emptying.

Heart failure caused by abnormal myocardial relaxation during DIASTOLE leading to defective cardiac filling.

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