跳至主要内容
临床试验/NCT02699944
NCT02699944已完成不适用

Optimization of Cardiac Resynchronization Therapy Using an ECG Vest

Alan J. Bank, MD1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Change in left ventricular end-systolic volume

研究概览

简要总结

Despite advancements in implant technology and various techniques of optimization, there is still around 30% non-responder rate to cardiac resynchronization therapy (CRT). This study will assess the potential benefit of a body surface mapping technology to optimize CRT devices in the chronic sub-optimal responder setting.

详细描述

Cardiac resynchronization therapy (CRT) is one of the most important advances in the treatment of patients with heart failure (HF). This therapy, also known as biventricular pacing, utilizes pacemaker leads to synchronize the contraction of the walls within the left ventricle (LV) and the contraction of the left and right ventricles. Many randomized trials have conclusively demonstrated that CRT improves symptoms, LV structure and function, hospitalization rates, and survival in appropriately selected HF patients. Nonetheless, approximately 30% of CRT patients will be "non-responders" because they will not demonstrate the expected clinical and/or echocardiographic improvement following therapy. A critical component of assessing CRT efficacy during the optimization clinic will be the use of a novel method of body surface electrocardiographic mapping under development by Medtronic, called the ECG Vest. In this proposal, we describe a research study to assess the potential benefit of using the ECG Vest as part of a CRT optimization strategy on clinical and echocardiographic outcomes (heart size and function) of patients receiving standard clinical care in the UHVC CRT Optimization Clinic.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • •Patients (or their legal guardian) must be willing to provide Informed Consent and a data privacy (HIPPA) authorization
  • •Patient is or will be followed clinically in the UHVC CRT Optimization Clinic
  • •Patient has been implanted with a CRT device for at least 6 months
  • •Patient received an echocardiogram prior to CRT implant
  • •Patients must be ≥ 18 years of age

排除标准

  • •Patient's EF is currently ≥ 50%
  • •Patients who are pregnant
  • •Patient has unhealed / open wounds on the torso and/or has a history of severe allergic reactions from ECG gel / electrode glue

研究组 & 干预措施

CRT sub-optimal responder

Experimental

Subjects who have had CRT for at least 6 months and who have not responded as well as they could, in their cardiologists opinion. Subjects' ejection fraction are still <50% despite CRT. A ECG Vest Optimization protocol will be utilized as one aspect to determine the best CRT programming for each individual subject.

干预措施: ECG Vest Optimization (Device)

结局指标

主要结局

Change in left ventricular end-systolic volume

时间窗: 6 months after optimization

次要结局

  • Determine the degree to which echocardiographic measures of LV function correlate with ECG Vest measures(6 months after optimization)

研究者

发起方
Alan J. Bank, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alan J. Bank, MD

Medical Director of Research

Allina Health System

研究点 (1)

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