Safety Study of the Ventricular Partitioning Device (VPD) Implant System in Heart Failure Patients
Summary
The CardioKinetix Ventricular Partitioning Device (VPD) is intended to isolate the malfunctioning portion of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. By isolating the malfunctioning portion of the left ventricle, it is hypothesized that the left ventricle will pump more effectively.
Study Design
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Heart Failure
Intervention
VPD Implant System
Location
Washington Hospital Center
Washington
District of Columbia
United States
20010
Status
Recruiting
Source
CardioKinetix, Inc
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00573560
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Heart Failure
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.
Cardiomegaly
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.
Heart Failure, Systolic
Heart failure caused by abnormal myocardial contraction during SYSTOLE leading to defective cardiac emptying.
Heart Failure, Diastolic
Heart failure caused by abnormal myocardial relaxation during DIASTOLE leading to defective cardiac filling.
Angiotensin-converting Enzyme Inhibitors
A class of drugs whose main indications are the treatment of hypertension and heart failure. They exert their hemodynamic effect mainly by inhibiting the renin-angiotensin system. They also modulate sympathetic nervous system activity and increase prostaglandin synthesis. They cause mainly vasodilation and mild natriuresis without affecting heart rate and contractility.
Clinical Trials
Paracor Ventricular Support System (PVSS) for Patients With Heart Failure
This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor Ventricular Support System when used to treat patients with heart failure. The implant, which is...
Feasibility Study of an Integrated Diagnostic System to Manage Heart Failure
The purpose of this clinical trial is to evaluate the potential benefits of a new heart failure diagnostic system for heart failure patients with implanted cardiac resynchronization therap...
Rheos® Diastolic Heart Failure Trial
The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be fol...
The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms.
Heart Failure Patient Self-Management Web Portal Pilot Study
The proposed pilot project is aimed at assessing the feasibility, acceptability and impact of a web-based home tele-monitoring system among congestive heart failure patients at the Univers...
PubMed Articles
Atrial fibrillation is the most common arrhythmia and is especially clinically important in patients with heart failure. Prolonged atrial fibrillation with high ventricular rate response may lead to d...
Autonomic nervous system dysfunction in advanced systolic heart failure.
An alteration of the autonomic nervous system has been described in heart failure (HF). The aim of this study was to assess, compare and relate the impairment of both arms of the autonomic nervous sys...
The purpose of this study was to compare the diagnostic accuracy for the detection of infection between the culture of fluid obtained by sonication (SFC) and the culture of peri-implant tissues (PITC)...
Epidemiology of Anemia in Heart Failure.
Anemia is being increasingly recognized as an important comorbidity in patients with heart failure. Despite wide variations in defining anemia, approximately one-fifth to one-third of patients with he...
Systolic and diastolic heart failure are overlapping phenotypes within the heart failure spectrum.
