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The 4-SITE Field Following Study (4-SITE FF) (4-SITE FF)

2012年12月3日更新者：Guidant Corporation

RELIANCE QUADRIPOLAR DEFIBRILLATION LEADS (4-SITE)FIELD FOLLOWING The 4-SITE Field Following Study (4-SITE FF)

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.

研究概览

地位

完全的

条件

ICD and CRT-D Indicated Patients

详细说明

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)

研究类型

观察性的

注册 (实际的)

430

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

德国
- Nordrhein-Westfalen
  - Bad Oeynhausen、Nordrhein-Westfalen、德国、D - 32545
    - Bad Oeynhausen Herz- und Diabeteszentrum Nordrhein-Westfalen

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Study Population: Patients should be selected from the investigator's general population indicated for an ICD or CRT-D Implantation. The investigator has the responsibility of screening all potential patients and selecting those who meet study eligibility criteria.

描述

Inclusion Criteria:

Study Specific:

ICD / CRT-D Indication according to normal clinical practice
Patients receiving:
a single or dual chamber 4-SITE compatible ICD
or a 4-SITE compatible CRT-D
one of the RELIANCE 4-SITE defibrillation leads
Patients currently implanted with a pacemaker
upgraded to a 4-SITE compatible ICD or CRT-D (4-SITE header)
one of the RELIANCE 4-SITE defibrillation leads

General:

Willing and capable of providing informed consent for
undergoing a 4-SITE system implant,
participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol
Geographically stable patients who are available for follow-up at a study centre
Age 18 or above, or of legal age to give informed consent specific to national law

Exclusion Criteria:

Study Specific:

ICD and CRT-D Patients scheduled for a device replacement
CRM Patients who have or who would need an lead adaptor
All patients who have an active or non-active defibrillation lead other than 4-SITE

General:

Not willing and not capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation (including VT/VF shock conversion) at an approved clinical investigational centre and at the intervals defined by this protocol
Patients who were in NYHA Class IV during the last 3 month
Patients with pre-existing diseases, which may confound study results
Patients currently requiring dialysis,
Cancer patients
Patients with drug and/or alcohol abuse history
Life expectancy < 12 months (or expected heart transplant within 12 months)
Patients on a Heart Transplant List
Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion.
Enrolled in any other concurrent study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

时间观点：预期

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Appropriate Detection of induced VT 大体时间：At Implant or during VT/VF testing up to one month after implant	Induced mean VT/VF detection time < 4.5 seconds	At Implant or during VT/VF testing up to one month after implant
Appropriate induced VT/VF Shock Conversion 大体时间：At Implant or during testing within one month after implant	Successful VT/VF conversions (with 41 J, no external shock) will be 93% or higher	At Implant or during testing within one month after implant
Appropriate pacing thresholds at follow-up with the 4-SITE defibrillation leads 大体时间：entire duration of the study	Mean pacing threshold post implant ≤ 1.5V	entire duration of the study
Appropriate Lead Impedances as a measure of lead integrity over 12 month time 大体时间：entire study duration	Shocking lead impedance should be within the range of 20 and 80 OHM Pace /sense lead impedance within 200 and 2000 OHM	entire study duration
Appropriate sensing and absence of artefacts 大体时间：entire duration of study	Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU	entire duration of study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Guidant Corporation

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年5月1日

初级完成 (实际的)

2011年1月1日

研究完成 (实际的)

2011年1月1日

研究注册日期

首次提交

2009年6月12日

首先提交符合 QC 标准的