RELIANCE QUADRIPOLAR DEFIBRILLATION LEADS (4-SITE)FIELD FOLLOWING The 4-SITE Field Following Study (4-SITE FF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Appropriate induced VT/VF Shock Conversion
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
- •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
结局指标
主要结局
Appropriate induced VT/VF Shock Conversion
时间窗: 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
Appropriate sensing and absence of artefacts
时间窗: entire duration of study
Appropriate sensing and absence of artefacts during standardized pocket manipulations and standardized provocative maneuvers during FU
Appropriate Detection of induced VT
时间窗: At Implant or during VT/VF testing up to one month after implant
Induced mean VT/VF detection time \< 4.5 seconds
Appropriate pacing thresholds at follow-up with the 4-SITE defibrillation leads
时间窗: entire duration of the study
Mean pacing threshold post implant ≤ 1.5V
Appropriate Lead Impedances as a measure of lead integrity over 12 month time
时间窗: 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
次要结局
未报告次要终点