Cardiac Anodal Biphasic Pacing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Clinically significant maximum rate of pressure change maximum rate of pressure change within the left ventricle during its contraction phase- dP/dtmax.
研究概览
简要总结
The goal of this study is to test a new pacing method called anodal biphasic pacing (ABP) to determine if this pacing works as well-or better-than current pacing methods. This new method may improve how the heart works and reduce some of the problems caused by regular pacing.
Current implantable pacemakers use a monophasic cathodal waveform to stimulate the heart. Monophasic cathodal pacing (MCP) waveforms slow conduction, impair contractility, cause inflammation, increase risk of atrial fibrillation, heart failure, and mortality. Anodal biphasic pacing (ABP) is an alternative waveform that can stimulate the heart. ABP preconditions the heart and then initiates cardiac contraction. ABP may address the limitations of MCP.
详细描述
This study is a single-center, prospective, investigator-initiated, non-randomized, study that will investigate ABP in patients with structurally normal hearts and those with non-ischemic cardiomyopathy who are undergoing interventional cardiac procedure, generator exchange of dual chamber Cardiac implantable electronic device (CIED), or de novo implant or generator exchange of CIED with cardiac resynchronization therapy.
Eligible participants, without heart disease and those with nonischemic cardiomyopathy, undergoing CIED implant or generator exchange or interventional cardiac procedure at Boston Medical Center will be screened and prospectively enrolled. Participants will be stratified by left ventricular ejection fraction (EF): those with severely reduced EF (≤35%), mid-range EF (> 35%-49%) and normal EF (EF≥ 50%).
Primary efficacy objectives:
- To identify which patient populations have the greatest and most consistent hemodynamic benefit from ABP as compared with cathodal pacing.
- To confirm that ABP does not negatively impact non-responders.
- To define the ideal anodal biphasic waveform characteristics (amplitude and pulse width) that maximizes the positive effect in subjects who demonstrate hemodynamic improvement ABP
- To assess differences in capture thresholds between anodal biphasic and cathodal pacing.
Secondary safety objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Planned interventional cardiac procedure
- •Planned generator exchange of dual chamber cardiac implantable electronic device (CIED)
- •Functioning atrial lead
- •Planned de novo implant or generator exchange of CIED with cardiac resynchronization therapy
- •Functioning atrial lead
排除标准
- •Permanent atrial fibrillation
- •Third degree AV block without stable escape rhythm
- •Ischemic heart disease or coronary disease > 40%
- •Unable to receive heparin
- •Are not fluent in English
- •Unable to read in English
- •Not able to provide informed consent
- •Women who are pregnant
研究组 & 干预措施
Cohort A
Cardiac patients who are undergoing interventional cardiac procedure including electrophysiology (EP) with planned retrograde left ventricular access or diagnostic coronary catheterization.
干预措施: Cardiac Waveform Generator (Device)
Cohort B
Patients who have pacing indication and are undergoing routine generator exchange of dual chamber cardiac implantable electronic device (CIED).
干预措施: Cardiac Waveform Generator (Device)
Cohort C
Patients who are undergoing new implant or generator exchange of CIED with cardiac resynchronization therapy.
干预措施: Cardiac Waveform Generator (Device)
结局指标
主要结局
Clinically significant maximum rate of pressure change maximum rate of pressure change within the left ventricle during its contraction phase- dP/dtmax.
时间窗: about 30 minutes
Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in dP/dtmax.
Clinically significant stroke work
时间窗: about 30 minutes
Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in stroke work.
Clinically significant left ventricular end-diastolic pressure (LVEDP)
时间窗: about 30 minutes
Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in LVEDP.
Clinically significant diastolic relaxation (tau)
时间窗: about 30 minutes
Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in tau.
Clinically significant volume measurements
时间窗: about 30 minutes
Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in volume measurements.
Capture threshold
时间窗: about 30 minutes
This outcome will be measured with decremental pacing threshold testing where pacing output (voltage or pulse width) is decremented until there is a loss of ventricular capture. The minimum output prior to loss of capture is defined as the capture threshold.
Clinically significant maximum rate of pressure change maximum rate of pressure change within the left ventricle during its contraction phase- dP/dtmax.
时间窗: about 30 minutes
Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in dP/dtmax.
Clinically significant stroke work
时间窗: about 30 minutes
Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in stroke work.
Clinically significant left ventricular end-diastolic pressure (LVEDP)
时间窗: about 30 minutes
Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in LVEDP.
Clinically significant diastolic relaxation (tau)
时间窗: about 30 minutes
Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in tau.
Clinically significant volume measurements
时间窗: about 30 minutes
Response will be expressed as a percent change in these measures with anodal biphasic pacing (ABP) as compared with cathodal pacing. A clinically significant hemodynamic response to pacing will be defined as a \>10% increase in volume measurements.
Capture threshold
时间窗: about 30 minutes
This outcome will be measured with decremental pacing threshold testing where pacing output (voltage or pulse width) is decremented until there is a loss of ventricular capture. The minimum output prior to loss of capture is defined as the capture threshold.
次要结局
- Waveform safety concerns(about 30 minutes)
- Device safety issues(about 30 minutes)
- Procedural safety issues(about 30 minutes)
- Waveform safety concerns(about 30 minutes)
- Device safety issues(about 30 minutes)
- Procedural safety issues(about 30 minutes)