TRIAGE-CRT Telemonitoring in Patients With CHF and Indication of CRT-D
This feasibility study will investigate the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up treatment of patients implanted with a Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillator (CRT-D). The feasibility study is designed to plan and define endpoints for a larger randomized study. The study will assess the HM-parameter trends correlation with daily weight and blood pressure changes. The patient compliance rate of the two different telemonitoring systems (HM & ETM) will also be evaluated.
This single-arm, multi-center feasibility study will explore the clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) and weight and blood pressure (BP) external telemonitoring (ETM) in the follow-up management of heart failure patients implanted with a Cardiac Resynchronization Therapy Implantable Cardioverter Defibrillator (CRT-D). The BIOTRONIK Home Monitoring system will automatically and remotely collect device based information on a daily basis, and an external telemonitoring system will be used to determine the 'weight' and 'blood pressure' remotely at the patient's home on a daily basis. This study will evaluate retrospectively, if Home Monitoring parameters correlate with weight and blood pressure changes. The patient compliance rate of the two telemonitoring systems will also be assessed.
Target enrollment is up to 100 patients at 15 U.S. sites. Patients will be enrolled within a period of 12 to 15 months. Based on the follow-up period of 6 months per patient, the study duration is 18 to 21 months from the date of first patient enrollment. All patients will give written informed consent prior to enrollment and will be implanted with the legally marketed BIOTRONIK Kronos LV-T, or an appropriate BIOTRONIK CRT-D, as well as legally marketed pacing and defibrillation leads. In addition, all patients will be receiving a legally marketed external telemonitoring system to determine weight and blood pressure at home.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Congestive Heart Failure
Kronos LV-T, Lumax HF-T
Maricopa Medical Center
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00395642
- Information obtained from ClinicalTrials.gov on July 15, 2010
A pilot study to examine the effects of LDL-Apheresis on patients with Stage III Congestive Heart Failure. Study hypothesis: Decreased blood viscosity from receiving LDL-apheresis will de...
The purpose of this study is to compare the effects on heart rate and ventricular arrhythmias (irregular heart beats) of two doses of NatrecorÂ® (a recombinant form of the natural human ...
The purpose of the study is to recognize main causes of acute decompensation of chronic congestive heart failure.
This study will assess the safety and efficacy of DITPA relative to placebo in patients with New York Heart Association (NYHA) class III or IV congestive heart failure (CHF) who have low s...
The purpose of this study is to determine whether a new medicine, called carvedilol, improves symptoms and heart function in children who have congestive heart failure (diminished function...
It remains unknown how sildenafil acutely provides hemodynamic alterations in patients with decompensated congestive heart failure. The aim of this study was to investigate whether myocardial and/or h...
The aim of this study was to examine the impacts of multiple indicators of Socio-economic Status (SES) on Congestive Heart Failure (CHF) related readmission.
Acute promyelocytic leukemia (APL) is a highly curable malignancy. However, 30% of patients die during therapy induction from bleeding, differentiation syndrome (DS), and/or infection. Recommendations...
A 5-year-old domestic shorthair cat that had been previously diagnosed with diabetes mellitus was presented for episodes of coughing and respiratory distress. Diagnostic testing revealed congestive he...
Pneumatic leg sleeves are widely used following prolonged operations for prevention of venous stasis. In healthy volunteers they increased cardiac function. We evaluated the hemodynamic effects and th...
Medical and Biotech [MESH] Definitions
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)
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).
A semisynthetic digitalis glycoside with the general properties of DIGOXIN but more rapid onset of action. Its cardiotonic action is prolonged by its demethylation to DIGOXIN in the liver. It has been used in the treatment of congestive heart failure (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.
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).