NCT01993862

Same Day Discharge (SDD) After Implantable Cardioverter Defibrillator (ICD) Implant

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Failure
• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	Same Day Discharge	Patients will send device data remotely to their physician on the day of discharge from the hospital and again 24 hours after discharge from the hospital.

Timeline

• Start date: 2014-03-17
• Primary completion: 2016-08-05
• Completion: 2016-08-12
• First posted: 2013-11-25
• Last updated: 2019-02-04

Locations

28 sites across 1 country: United States