Attain Model 4196 Left Ventricular (LV) Lead
2009年9月24日 更新者：Medtronic Cardiac Rhythm and Heart Failure
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 changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat.
In certain heart failure cases, when the two lower chambers of the heart no longer beat in a coordinated manner, cardiac resynchronization therapy (CRT) may be prescribed.
CRT is similar to a pacemaker.
It is placed (implanted) under the skin of the upper chest.
CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads (flexible insulated wires) that are inserted through the veins to the heart.
The purpose of this study is to evaluate a new lead for delivering energy to the left ventricle (bottom left chamber of the heart).
研究概览
研究类型
介入性
注册 (实际的)
190
阶段
- 不适用
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
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Alberta
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Calgary、Alberta、加拿大
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Edmonton、Alberta、加拿大
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Ontario
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Toronto、Ontario、加拿大
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Quebec
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Montreal、Quebec、加拿大
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Sainte-Foy、Quebec、加拿大
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Alaska
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Anchorage、Alaska、美国
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Arizona
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Phoenix、Arizona、美国
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California
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Long Beach、California、美国
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Palo Alto、California、美国
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Iowa
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Davenport、Iowa、美国
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Kentucky
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Lexington、Kentucky、美国
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Louisiana
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Baton Rouge、Louisiana、美国
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Michigan
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Detroit、Michigan、美国
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Minnesota
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Minneapolis、Minnesota、美国
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Missouri
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Kansas City、Missouri、美国
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North Carolina
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Raleigh、North Carolina、美国
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Ohio
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Mayfield Heights、Ohio、美国
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Pennsylvania
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Wynnewood、Pennsylvania、美国
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South Carolina
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Spartanburg、South Carolina、美国
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Tennessee
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Kingsport、Tennessee、美国
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Memphis、Tennessee、美国
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Texas
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Dallas、Texas、美国
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Fort Worth、Texas、美国
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Vermont
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Burlington、Vermont、美国
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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
描述
Inclusion Criteria:
- QRS greater than or equal to 120 milliseconds (The QRS interval is a measurement of how the electrical signal involved in a heart beat travels, or is conducted, through the ventricles. A wide QRS (more than 120) suggests that there is a conduction problem, or block, in the ventricles.)
- Left Ventricular Ejection Fraction (EF) less than or equal to 35 percent (Ejection Fraction is a measurement of how well the left ventricle pumps blood out to the rest of the body. The higher the EF the more blood the ventricle is pumping.)
- Subject has moderate to severe heart failure despite medications
Exclusion Criteria:
- Subjects with a previous lead in the left ventricle or previous implant attempt within 30 days of implant or ongoing complications from a previous unsuccessful attempt
- Subjects with chest pain or who have had a heart attack within the past month before enrollment in the study
- Subjects that have had certain surgeries on their heart within the past three months
- Subjects with chronic (permanent) fast heart beats in the upper chambers of the heart (atrial arrhythmias)
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
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：4196 Lead
Non-randomized study.
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研究装置的植入和随访
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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 |
|---|---|---|
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Safety (Subjects Without a Model 4196 Lead Related Complication)
大体时间：One Month
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A subject who was free of a Model 4196 lead related complication by one month visit.
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One Month
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Efficacy (Pacing Voltage Thresholds of Distal Tip Electrode)
大体时间：One Month
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Model 4196 lead distal tip electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])
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One Month
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Efficacy (Pacing Voltage Threshold of Proximal Ring Electrode)
大体时间：Three Months
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Model 4196 lead proximal ring electrode mean pacing voltage threshold (at 0.5 milliseconds [ms])
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Three Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Subjects Successfully Implanted With Model 4196 Lead
大体时间：Implant
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A successful implant occurs when the Model 4196 lead is implanted in the left ventricle of the heart and functions appropriately.
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Implant
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Subjects Successfully Implanted After Cannulation
大体时间：Implant
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A successful implant occurs when the coronary sinus (CS) is successfully cannulated and a left ventricular lead is implanted in the left ventricle of the heart and functions appropriately.
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Implant
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All Left Ventricular Leads
大体时间：Implant
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All left ventricular leads successfully implanted
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Implant
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All Medtronic Left Ventricular Leads (Attain Family)
大体时间：Implant
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All Medtronic left ventricular leads (Lead Model Numbers included 4193, 4194, 4195 and 4196) successfully implanted
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Implant
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Cannulation Time
大体时间：Implant
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Cannulation time was defined as the time from insertion of the first CS cannulation catheter to the first CS cannulation.
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Implant
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Fluoroscopy Time
大体时间：Implant
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Fluoroscopy time was defined as the total time the fluoroscope was imaging.
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Implant
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Model 4196 Lead Placement Time
大体时间：Implant
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Model 4196 lead placement time was defined as the time from insertion of the successfully placed lead to the time when it was placed in the first acceptable pacing location.
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Implant
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Total Implant Time
大体时间：Implant
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Total implant time was defined as time from initial incision to final closure.
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Implant
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Assessment of Lead Handling Characteristics
大体时间：Implant
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Lead handling characteristics assessed as "acceptable" by physicians
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Implant
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Electrical Performance - Tip Electrode: Sensing
大体时间：12-month
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Model 4196 lead tip electrode R-wave amplitude
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12-month
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Electrical Performance - Tip Electrode: LV Voltage Threshold
大体时间：12-month
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Model 4196 lead tip electrode LV voltage threshold
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12-month
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Electrical Performance -Tip Electrode: Pacing Impedance
大体时间：12-month
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Model 4196 lead tip electrode pacing impedance
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12-month
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Electrical Performance -Ring Electrode: Sensing
大体时间：Implant
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Model 4196 lead ring electrode R-wave amplitude
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Implant
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Electrical Performance - Ring Electrode: LV Voltage Threshold
大体时间：12-month
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Model 4196 lead ring electrode LV voltage threshold
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12-month
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Electrical Performance -Ring Electrode: Pacing Impedance
大体时间：12-Month
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Model 4196 lead ring electrode pacing impedance
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12-Month
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Summarize All Adverse Events
大体时间：Up to 18 months
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All adverse events were collected for this trial such as, but not limited to, the following: Atrial Fibrillation, Chest Pain, Pneumonia, Cold/Flu
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Up to 18 months
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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。
调查人员
- 首席研究员：Brian Ramza, MD, PHD、St. Luke's Mid America Heart Institute, Kansas City MO
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
2007年2月1日
初级完成 (实际的)
2007年8月1日
研究完成 (实际的)
2008年12月1日
研究注册日期
首次提交
2005年12月28日
首先提交符合 QC 标准的
2005年12月30日
首次发布 (估计)
2006年1月2日
研究记录更新
最后更新发布 (估计)
2009年9月28日
上次提交的符合 QC 标准的更新
2009年9月24日
最后验证
2009年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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