CTRI/2012/05/002669Other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 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
- 入组人数
- 990
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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.
- •11. Receiving regularly scheduled intravenous (IV) inotropic therapy as part of their drug regimen.
- •12. Subjects that have received a heart or lung transplant.
- •13. Receiving mechanical circulatory support.
- •14. Subjects who have been referred or admitted for Hospice care.
- •15. A life expectancy of less than 12 months per physician discretion.
- •16. Enrolled in any concurrent study without Boston Scientific written approval.
- •17. Subjects whose devices have previously been converted to the SRD-1 and withdrawn from this study.
- •18. Subjects who have received a sub-pectoral COGNIS implant prior to February 1st 2011 that has a dash number listed in APPENDIX K.
- •19. Women who are known to be pregnant or plan to become pregnant within the course of the study.
- •20. LV offset is programmed to a value greater than zero
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