CTRI/2012/05/002669
Other
未知
Multisensor Chronic Evaluations in Ambulatory Heart Failure Patients - MultiSENSE
Guidant Europe a Boston Scientific Company0 个研究点目标入组 990 人待定
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Health Condition 1: null- Heart Failure
- 发起方
- Guidant Europe a Boston Scientific Company
- 入组人数
- 990
- 状态
- Other
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Age 18 or above, or of legal age to give informed consent specific to state and national law.
- •2\. Willing and capable of returning for all follow\-up visits and emergency care at the investigational center as medically appropriate.
- •3\. Willing to participate in all testing associated with this clinical investigation at an approved clinical investigational center.
- •4\. Currently implanted with a CRT\-D system including a COGNIS device (model N119, N120, P107 or P108\) with RA, RV and LV leads
- •5\. Currently classified as NYHA Class II, III or IV within the last six months
排除标准
- •1\. Inability or refusal to sign the Subject Informed Consent.
- •2\. Inability or refusal to comply with the follow\-up schedule.
- •3\. Documented as pacemaker dependent.
- •4\. Unable to rest comfortably in a semi\-recumbent position for up to 20 minutes.
- •5\. Implanted with active Medtronic Fidelis lead models: 6930, 6931, 6948 or 6949\.
- •6\. Currently implanted with unipolar RA, RV, or LV leads.
- •7\. LV sensitivity programmed to less than 0\.7 mV AGC.
- •8\. Subjects that have a history of appropriate Tachycardia Therapy (external or implanted) for rates 165 bpm within 1 week prior to enrollment.
- •9\. Device battery status indicates approximate time to explant 2 years.
- •10\. 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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