The 4-SITE Field Following Study (4-SITE FF)
Summary
The purpose of this study is to evaluate and document appropriate clinical performance of the new 4-SITE Header / Lead interface in the TELIGEN 100 HE 4-SITE (VR and DR) implantable cardioverter defibrillator (ICD) PGs (Models F103; F111), the COGNIS 100 HE 4-SITE cardiac resynchronization therapy ICD (CRT-D) PG (Model P108) when connected to any of the RELIANCE Quadripolar (4-SITE) defibrillation leads.
Appropriate clinical performance of system components of the 4-SITE systems other than the new 4-SITE header / lead interface has been evaluated and documented already in the previously conducted COGNIS and TELIGEN 100 HE FIELD FOLLOWING STUDY, The COGENT-4 Field Following Study.
Data collected may be used to support international regulatory submissions including the FDA and the Japanese Ministry of Health, Labour and Welfare.
Description
The following devices will be used (all are CE-marked):
- TELIGEN 100 HE 4-SITE (Single and Dual Chamber ICD)
- Model Number: F103 (Quadripolar, VR);
- Model Number: F111 (Quadripolar, IS-1, DR)
- COGNIS 100 HE 4-SITE (CRT-D)
o Model Number: P108 (Quadripolar, IS-1, IS-1)
- RELIANCE 4-SITE leads (12 different model numbers in total as shown in the table below)
Study Design
Time Perspective: Prospective
Conditions
ICD and CRT-D Indicated Patients
Location
Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen
Nordrhein-Westfalen
Germany
D - 32545
Status
Active, not recruiting
Source
Guidant Corporation
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00920452
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Visitors To Patients
Patients' guests and rules for visiting.
Ethics, Nursing
The principles of proper professional conduct concerning the rights and duties of nurses themselves, their patients, and their fellow practitioners, as well as their actions in the care of patients and in relations with their families.
Moving And Lifting Patients
Moving or repositioning patients within their beds, from bed to bed, bed to chair, or otherwise from one posture or surface to another.
Fungemia
The presence of fungi circulating in the blood. Opportunistic fungal sepsis is seen most often in immunosuppressed patients with severe neutropenia or in postoperative patients with intravenous catheters and usually follows prolonged antibiotic therapy.
Day Care
Institutional health care of patients during the day. The patients return home at night.
Clinical Trials
None
PubMed Articles
Analysis of the Reasons for not Undergoing Laser Corneal Refractive Surgery in 611 Patients.
To determine and analyze the reasons for patients not undergoing laser corneal refractive surgery. A retrospective observational study was conducted to analyze the reasons for not undergoing laser cor...
Melanoma with unknown primary: report and analysis of 24 patients.
In the literature, there are some papers reporting on patients with metastatic melanoma from an unknown primary lesion (MUP). The pathogenesis of this phenomenon and the prognosis of these patients ar...
Abstract The quality of life (QoL) at the time of the diagnosis of myeloproliferative neoplasm (MPN) has, so far, not been studied. One hundred and seventy-nine MPN patients; 80 ET, 73 PV, 22 PMF and...
Risk Factors for Mortality in Stable Peritoneal Dialysis Patients.
Background: The mortality rates of end-stage renal disease patients have significantly declined over the past decade. However, there are few reports on the risk factors for mortality in stable periton...
Background: In this subanalysis of the CASE-J, which was conducted to compare the effects of candesartan and amlodipine in Japanese high-risk hypertensive patients, the association of left ventricular...
