跳至主要内容
临床试验/NL-OMON37715
NL-OMON37715
已完成
不适用

Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients (MultiSENSE) - MultiSENSE

Boston Scientific0 个研究点目标入组 100 人待定

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。

注册库
who.int
开始日期
待定
结束日期
待定
最后更新
2年前
研究类型
Observational invasive

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

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