Advertisement

Topics

AIGISRx Envelope for Prevention of Infection Following Replacement With a Cardiac Resynchronization Therapy Device (CRT)

2014-07-23 21:11:12 | BioPortfolio

Summary

The purpose of this study is to compare the incidence of cardiac rhythm management device (CRMD) infection and CRMD mechanical complication after CRMD replacement with a cardiac resynchronization therapy device (CRT) and AIGISRx Anti-Bacterial Envelope, to the incidence after replacement with a CRT and no AIGISRx.

Description

Cardiac rhythm management device (CRMD) infection is associated with significant morbidity and expense. The frequency of CRMD infection is increasing faster than the frequency of CRMD implants, suggesting more effective prophylactic strategies are needed.

The AIGISRx Anti-Bacterial Envelope is an FDA-cleared polypropylene mesh that is intended to securely hold a pacemaker pulse generator or defibrillator (ICD) in order to create a stable environment when implanted in the body. It contains the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection in an in vivo model of bacterial contamination following surgical implant of the generator or defibrillator.

This is a prospective, observational, multicenter registry of subjects undergoing CRMD replacement with a CRT and AIGISRx, with or without lead revision/addition. The registry subjects will be compared to a case-matched retrospective control group undergoing CRMD replacement with a CRT and no AIGISRx, with or without lead revision/addition. The primary study endpoints are major CRMD infection and CRMD mechanical complication during the 12 months following CRMD replacement with a CRT.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Conditions

Cardiac Rhythm Management Device Infection

Location

Princeton Medical Center
Birmingham
Alabama
United States
35211

Status

Recruiting

Source

TYRX, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:12-0400

Clinical Trials [2189 Associated Clinical Trials listed on BioPortfolio]

Clinical Study to Confirm MRI Safety and Effectiveness Using St. Jude Medical (SJM) Cardiac Rhythm Management Systems

This is a clinical investigational plan (CIP) for the "Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)". This study intends ...

Atrial Fibrillation Screening With a Smartphone Device and iECG (ElectroCardioGram) Application

Question: Can Atrial Fibrilation (AF) cases in patients ≥ 65 years be easily detected in a primary healthcare environment using a smartphone device and iECG application as an opportunist...

PANORAMA 2 Observational Study

Understanding the clinical practice of treatment of cardiac rhythm disorders all over the world and understanding the clinical outcomes of the treatment with its cardiac rhythm products in...

AIGISRx Envelope for Prevention of Infection Following Replacement With an Implantable Cardioverter-Defibrillator (ICD)

The purpose of this study is to compare the incidence of cardiac rhythm management device (CRMD) infection and CRMD mechanical complication after CRMD replacement with an Implantable Cardi...

InSync Implantable Cardioverter Defibrillator Registry: Cardiac Resynchronization Therapy

Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes. When there are ch...

PubMed Articles [18886 Associated PubMed Articles listed on BioPortfolio]

Device-detected subclinical atrial tachyarrhythmias: definition, implications and management-an European Heart Rhythm Association (EHRA) consensus document, endorsed by Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS) and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE).

Gorenek B, et al. Device-detected subclinical atrial tachyarrhythmias: definition, implications and management-an European Heart Rhythm Association (EHRA) consensus document, endorsed by Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS) and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE).

Perioperative management of cardiac rhythm assist devices in ambulatory surgery and nonoperating room anesthesia.

Patients with cardiac implantable electronic devices (CIEDs) frequently undergo various surgical procedures and in the past perioperative management involved only placing magnet over the device. New p...

Rhythm profiles and survival after out-of-hospital ventricular fibrillation cardiac arrest.

Treatment: protocols for cardiac arrest rely upon rhythm analyses performed at two-minute intervals, neglecting possible rhythm changes during the intervening period of CPR. Our objective was to descr...

The wearable cardioverter defibrillator as a bridge to reimplantation in patients with ICD or CRT-D-related infections.

The approach to treat device infection in patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) is a challenging procedure. Optimal trea...

Medical and Biotech [MESH] Definitions

A cardiac arrhythmia that is caused by interaction of two independently initiated cardiac impulses of different rates from two separate foci. Generally one focus is the SINOATRIAL NODE, the normal pacemaker. The ectopic focus is usually in the HEART VENTRICLE but can be in the HEART ATRIUM or the ATRIOVENTRICULAR NODE. Modulation of the parasystolic rhythm by the sinus rhythm depends on the completeness of entrance block surrounding the parasystolic focus.

Method in which prolonged electrocardiographic recordings are made on a portable tape recorder (Holter-type system) or solid-state device ("real-time" system), while the patient undergoes normal daily activities. It is useful in the diagnosis and management of intermittent cardiac arrhythmias and transient myocardial ischemia.

An electrical current applied to the HEART to terminate a disturbance of its rhythm, ARRHYTHMIAS, CARDIAC. (Stedman, 25th ed)

A biological rhythm with a period shorter than 24 hours.

A biological rhythm with a period longer than 24 hours.

More From BioPortfolio on "AIGISRx Envelope for Prevention of Infection Following Replacement With a Cardiac Resynchronization Therapy Device (CRT)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Infectious-diseases
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...


Searches Linking to this Trial