Safety and Effectiveness of Cardiac Resynchronization Therapy With Defibrillation
Summary
The purpose of this study was to determine if cardiac resynchronization therapy when combined with defibrillation is safe and effective in the treatment of symptomatic heart failure.
Description
Patients enrolled received a device with cardiac resynchronization therapy (CRT) and defibrillation. Patients were randomized to CRT on or off for up to six months and evaluated for mortality, hospitalization, and functional outcomes including exercise capacity, quality of life, symptomatic status, and echocardiographic analysis.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Heart Failure, Congestive
Intervention
Cardiac Resynchronization Therapy with Defibrillation
Location
Multiple locations
Saint Paul
Minnesota
United States
55112
Status
Completed
Source
Boston Scientific Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00387803
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Cardiotonic Agents
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).
Cardiac Resynchronization Therapy
The restoration of the sequential order of contraction and relaxation of the HEART ATRIA and HEART VENTRICLES by atrio-biventricular pacing.
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.
Cardiomyopathy, Alcoholic
Disease of CARDIAC MUSCLE resulting from chronic excessive alcohol consumption. Myocardial damage can be caused by: (1) a toxic effect of alcohol; (2) malnutrition in alcoholics such as THIAMINE DEFICIENCY; or (3) toxic effect of additives in alcoholic beverages such as COBALT. This disease is usually manifested by DYSPNEA and palpitations with CARDIOMEGALY and congestive heart failure (HEART FAILURE).
Digoxin
A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)
Clinical Trials
This study provides a continued access registry for cardiac resynchronization therapy with defibrillation (CRT-D), which helps to resynchronize (coordinate) the rhythm of the heart by help...
Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure
The purpose of this study is to determine whether combined mortality and hospitalization in heart failure patients receiving optimal pharmacologic therapy can be reduced by combining optim...
A new therapy for patients with advanced heart failure (HF) involves the implantation of a specialized pacemaker device (Cardiac Resynchronization Therapy, CRT) that attempts to restore th...
Resynchronization/Defibrillation for Ambulatory Heart Failure Trial
Congestive heart failure (CHF) is a common health problem that leads to frequent hospitalizations and an increased death rate. In spite of advances in drug therapy, it remains a significan...
Efficiency Study of Triple-Site Cardiac Resynchronization in Patients With Heart Failure
The purpose of this study is to assess the efficiency of permanent biventricular pacing using three ventricular leads in terms of reduction in adverse cardiac events rates, improvement in...
PubMed Articles
Cardiac resynchronization therapy for patients with atrial fibrillation.
Atrial fibrillation and chronic heart failure are two major and even growing cardiovascular conditions that often coexist. Cardiac resynchronization therapy is an important, device-based, non-pharmaco...
Asymptomatic Sustained Ventricular Fibrillation in a Patient With Left Ventricular Assist Device.
Optimal medical treatment, cardiac resynchronization, and the use of an implantable cardioverter defibrillator are established therapies of severe congestive heart failure. In refractory cases, left v...
The aim of this study was to investigate the impact of cardiac resynchronization therapy (CRT) on right ventricular (RV) function and the influence of RV dysfunction on the echocardiographic and clini...
The role of cardiac resynchronization therapy in mild heart failure has become a focus of attention with the publication of recent clinical trials. We present a review of the data supporting implantat...
