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