Pacing for Heart Failure With Preserved Ejection Fraction (HFpEF)
2013年5月29日 更新者：Medtronic Cardiac Rhythm and Heart Failure
The purpose of this research study is to evaluate the safety of a new pacing method (Fusion Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a period of 4 months, and determine the effects on different measures of heart failure.
This new pacing method may allow the heart to pump more efficiently.
Participation in this study will last approximately 8 months.
研究概览
详细说明
Patients with an EF greater than 50% and a regional mechanical delay of >= 65ms (an indication of mechanical dyssynchrony) will receive an implantable cardioverter defibrillator (ICD) with a special pacing feature.
When the feature is active, the device wil pace the left ventricle to target improved pump efficiency.
Patients will have the feature active for 4 months and inactive for 4 months.
The order will be randomized and the patient will not know whether the pacing is active or not.
Echocardiography, biomarkers, exercise testing, quality of life (QOL) testing and device information will be used to compare the patient's status while the feature is active vs. inactive.
研究类型
介入性
注册 (实际的)
22
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。
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:
- Patients with quantitative ejection fraction (EF) of greater than 50 percent
- Patients with active heart failure (symptomatic American Heart Association/American College of Cardiology stage C) despite optimal medications
- Patients greater than 18 years of age
- Patients willing and able to give informed consent
- Patients available for appropriate follow-up times for the length of study
- Patients able to complete cardiopulmonary exercise (CPX) testing
- Patients expected lifespan is greater than 12 months beyond study enrollment
- Patients with a regional mechanical delay (RMD) (septal-lateral) greater than 65 milliseconds
Exclusion Criteria:
- Patients who have undergone cardiac surgery 60 days prior to enrollment
- Patients who have had a myocardial infarction 90 days prior to enrollment
- Patients with hemodynamically significant uncorrected cardiac valvular disease
- Patients with active myocarditis and amyloidosis (if documented)
- Patients with a permanent pacemaker
- Patients with creatinine greater than 2 milligrams per milliliter or estimated glomerular filtration rate (eGFR) less than 30 to 50 milliliters per hour
- Patients with permanent or chronic sustained atrial fibrillation (fibrillation lasting 7 days or more at a time)
- Patients with a PR interval greater than 250 milliseconds
- Patients with severe chronic obstructive pulmonary disease
- Patients with high risk coronary artery disease
- Patients who are or expect to become pregnant during this study
- Patients enrolled in concurrent studies which could confound the results of this study
- Patients with hypertrophic cardiomyopathy (obstructive or non-obstructive)
- Patients with infiltrative disease or restrictive cardiomyopathy
- Patients with indication for percutaneous coronary intervention (PCI) at enrollment
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：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Fusion Pacing OFF
Subjects initially randomized to the Fusion Pacing OFF Arm will receive the Fusion Pacing software download at the implant visit, but the Fusion Pacing software will be programmed OFF.
At 4 months subjects in this arm will crossover to the Fusion Pacing ON Arm.
|
Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
其他名称：
|
|
实验性的：Fusion Pacing ON
Subjects initially randomized to the Fusion Pacing ON Arm will receive the Fusion Pacing software download at the implant visit, and the Fusion Pacing software will be programmed ON.
At 4 months subjects in this arm will crossover to the Fusion Pacing OFF Arm.
|
Market approved InSync Sentry™ model 7298, dual chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy (CRT) including sequential biventricular pacing and OptiVol® fluid monitoring or market approved InSync Maximo™ model 7304 dual chamber ICD with CRT including sequential biventricular pacing.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Number of adverse events while the Fusion Pacing download is active vs. inactive.
大体时间：From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
|
Percentage of time the Fusion Pacing is active throughout a four-month follow-up period.
大体时间：From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change in Minnesota Living with Heart Failure Questionnaire score.
大体时间：From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
|
Change in peak VO2 during Cardio-pulmonary Exercise Testing (CPX).
大体时间：From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
|
Change in echocardiography measures: E/E', Ejection Fraction, LV EDV.
大体时间：From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
|
Change in NT-proBNP.
大体时间：From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
From baseline to 4-month follow-up visit, and 4-month follow-up visit to 8-month follow-up visit
|
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
- 学习椅：HFpEF Trial Leader、Medtronic
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
2010年6月1日
初级完成 (实际的)
2013年1月1日
研究完成 (实际的)
2013年1月1日
研究注册日期
首次提交
2010年1月8日
首先提交符合 QC 标准的
2010年1月8日
首次发布 (估计)
2010年1月11日
研究记录更新
最后更新发布 (估计)
2013年5月30日
上次提交的符合 QC 标准的更新
2013年5月29日
最后验证
2013年5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.