NL-OMON37715
已完成
不适用
Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients (MultiSENSE) - MultiSENSE
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- heart Fialure
- 发起方
- Boston Scientific
- 入组人数
- 100
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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 CRT\-D system including a COGNIS device (Model N119, N120, P107 or P108\) with RA, RV, and LV leads;Classified as NYHA Class II, III, or IV within the last 6 months
排除标准
- •Inability or refusal to sign the Patient Informed Consent
- •Inability or 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 \<0\.7mV AGC
- •Subjects that have a 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
结局指标
主要结局
未指定
相似试验
Unknown
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