Latin America Cardiac Resynchronization Therapy Study (LatAmCRT)
研究概览
详细说明
The purpose of this study is to provide local evidence regarding Cardiac Resynchronization Therapy (CRT), in both pacing and defibrillation devices across Latin America. The primary objective will focus on changes in left ventricular heart size and function measurements in subjects receiving CRT therapy. The following additional parameters will also be collected:
- Data on referral patterns in Latin America;
- Data on device implant (including delivery system, device information, and lead information);
- Clinical data on subject outcomes and changes (improved, unchanged, or worsened) in heart failure status as assessed by heart failure (HF) hospitalizations, New York Heart Association (NYHA) class, mortality, and Quality of Life (QOL) measured by the Patient Global Assessment;
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
-
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Baja California
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Tijuana、Baja California、墨西哥
- Hospital Angeles Tijuana
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Guanajuato
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Leon、Guanajuato、墨西哥、OUS
- Hospital Angeles Leon
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria: Implant of new CRT-D or CRT-P device (first-time implant), ACC/AHA/HRS/ESC guidelines for implant, NYHA Class II, III or IV, QRS duration >120 ms, LVEF < 35%, Receiving optimal medical/drug therapy, Able to give written informed consent, Are > 21 years of age, Must be able to return for follow-up visits as required, Are not pregnant or do not plan to get pregnant within the next 6 months, Have no physical limitations to perform Echo studies
Exclusion Criteria: Previous or existing CRT system implanted, Unwilling or unable to comply with specified follow-up schedule, Enrolled or intending to participate in another device study during the course of this study that requires specific treatment or device programming, Medical condition that may limit life expectancy to < 6 months
学习计划
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 |
|---|---|
|
无干预：No intervention
Mostly observational study with 1 patient global assessment.
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All market-approved Medtronic CRT-D and CRT-P devices will be used in this study.
All eligible devices are commercially released and will be used within their intended use per device labeling.
The study may include future market-approved devices as they become commercially available.
All market-approved leads may be used in the study.
Epicardial leads may be used in the study.
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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 |
|---|---|---|
|
Measure heart size and function changes as assessed by Doppler echocardiogram (Echo).
大体时间：6 Months
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Measure heart size and function changes as assessed by Doppler echocardiogram (Echo).
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6 Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
referral patterns; Report on device implant; Analyze subject clinical status as it pertains to heart failure (HF) hospitalizations, changes in NYHA class, mortality and QOL (Patient Global Assessment);
大体时间：6 Months
|
referral patterns; Report on device implant; Analyze subject clinical status as it pertains to heart failure (HF) hospitalizations, changes in NYHA class, mortality and QOL (Patient Global Assessment);
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6 Months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.