Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 975
- 试验地点
- 99
- 主要终点
- Heart Failure (HF) events
研究概览
简要总结
The goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.
详细描述
The purpose of MultiSENSE study is to collect data about patient events during worsening heart failure, determine how sensor measurements vary during patient daily activities and during the development and recovery from events of worsening heart failure, develop algorithms capable of detecting the onset of worsening heart failure prior to the overt presentation of patient symptoms using reference measurements: thoracic impedance, heart sounds, physiologic responses to activities and respiration.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age 18 or above, or of legal age to give informed consent specific to state and national law
- •Willing and capable of returning for all follow-up visits and emergency care at the investigational center as medically appropriate
- •Willing to participate in all testing associated with this clinical investigation at an approved clinical investigational center
- •Currently implanted with a COGNIS device (Model N119 or N120, P107, P108)
- •Classified as NYHA Class II, III or IV within the last six months
排除标准
- •Inability or refusal to sign the Subject Informed Consent
- •Inability of refusal to comply with the follow-up schedule
- •Documented as pacemaker dependent
- •Unable to rest comfortably in a semi-recumbent position for up to 20 minutes
- •Implanted with active Medtronic Fidelis lead models: 6930, 6931, 6948 or 6949
- •Currently implanted with unipolar RA, RV, or LV leads
- •LV sensitivity programmed to less than 0.7 mV AGC
- •History of appropriate tachycardia therapy (external or implanted) for rates < 165 bpm within 1 week prior to enrollment
- •Device battery status indicates approximate time to explant < 2 years
- •Likely to undergo lead or PG revision during the course of the study as determined by the investigator
- •Receiving regularly scheduled intravenous (IV) inotropic therapy as part of their drug regimen
- •Have received heart or lung transplant
- •Receiving mechanical circulatory support
- •Patients who have been referred or admitted for Hospice care
- •A life expectancy of less than 12 months per physician discretion
- •Enrolled in any concurrent study without Boston Scientific written approval
- •Devices previously converted to the SRD-1 and withdrawn from the study
- •Received a sub-pectoral COGNIS implant prior to February 1, 2011 with a dash number listed in Appendix K of the study protocol
- •Known pregnancy or plan to become pregnant within the course of the study
- •LV offset is programmed to a value greater than zero
结局指标
主要结局
Heart Failure (HF) events
时间窗: 12 Months
The primary objectives of this study are to determine how ambulatory sensor measurements change with worsening heart failure, and to develop multisensor detection algorithms. Additional data will be collected to compare sensor measurements against reference measurements when the subject is hospitalized for HF. Data from this study may also be used for determining prospective endpoints and sample sizes for future studies. There are no formal statistical primary or secondary endpoints defined for this study. Therefore, no formal tests of hypothesis will be conducted.
次要结局
未报告次要终点