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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure, Coronary Artery Disease

Intervention / Treatment
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* Other: Same Day Discharge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Next Day Discharge<br>The patient will have a 23 hour standard of care observational stay in the hospital after an implantable cardioverter defibrillator implant procedure. | |
| Active Comparator: Same Day Discharge<br>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. | Other: Same Day Discharge<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate at 1 week after an implantable cardioverter defibrillator implant |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost savings per patient |  | 1 week | 
| Complication rate at 6 months after an implantable cardioverter defibrillator implant |  | 6 months |