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临床试验/NCT01993862
NCT01993862已完成不适用

Safety and Cost Effectiveness of Same Day Discharge After Implantable Cardioverter-Defibrillator Implant Versus Next Day Discharge

Abbott Medical Devices55 个研究点 分布在 1 个国家目标入组 266 人开始时间: 2014年3月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
266
试验地点
55
主要终点
Complication rate at 1 week after an implantable cardioverter defibrillator implant

研究概览

简要总结

The purpose of this study is to determine whether it is safe to send patients home from the hospital on the same day following an implantable cardioverter defibrillator (ICD) implant.

详细描述

SDD for ICD is a prospective, randomized, multi-center study designed to show that SDD is safe in a defined patient population receiving an ICD implant and that this approach can be more cost effective for the hospital than the current NDD approach. Safety is to be demonstrated by showing that postoperative complications do not occur at a higher rate in the SDD group of patients when compared to the NDD group. Cost effectiveness is to be demonstrated by comparing health care utilization between the SDD and NDD groups for the first week post implantation. Patients who were implanted with a St. Jude Medical single or dual chamber ICD for primary prevention and who met all inclusion and exclusion criteria may be enrolled in the study. Patients areconsidered enrolled at the point of randomization.

Randomization is assigned in a 1:1 ratio between the NDD group and the SDD group. Patients will undergo study evaluations after implant, pre-discharge, 1-week and 6 months post implant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient has a St Jude Medical device that is compatible with Merlin.net (remote monitoring)
  • Patient is receiving an implantable cardioverter defibrillator for primary prevention
  • Patient lives within 50 miles of an emergency room or 24 hour urgent care
  • Patient is able to sign informed consent

排除标准

  • Patient experiences a complication during or 4 hours after implantable cardioverter defibrillator procedure
  • Physician elects to keep the patient in over night due to a change in medical condition or a pre-existing condition that requires administration of continuous blood thinners
  • Physician is unable to program the implantable cardioverter defibrillator to collect all required information remotely from device
  • Patient is pregnant

研究组 & 干预措施

Next Day Discharge

No Intervention

The patient will have a 23 hour standard of care observational stay in the hospital after an implantable cardioverter defibrillator implant procedure.

Same Day Discharge

Active Comparator

The patient will be discharged from the hospital the same evening after an implantable cardioverter defibrillator implant procedure. Follow up after surgery will be done via remote device follow up (1) on the day of discharge and (2) 24 hours after surgery.

干预措施: Same Day Discharge (Other)

结局指标

主要结局

Complication rate at 1 week after an implantable cardioverter defibrillator implant

时间窗: 1 week

次要结局

  • Cost savings per patient(1 week)
  • Complication rate at 6 months after an implantable cardioverter defibrillator implant(6 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (55)

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