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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Heart Failure

• Registration Number: NCT01993862
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Study Timeline

• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-22
• Study First Posted: 2013-11-25
• Study Start: 2014-03-17
• Primary Completion: 2016-08-05
• Study Completion: 2016-08-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complication rate at 1 week after an implantable cardioverter defibrillator implant	1 week

Secondary Outcome Measures

Name	Time	Method
Cost savings per patient	1 week
Complication rate at 6 months after an implantable cardioverter defibrillator implant	6 months

Trial Locations

Locations (28)

Heart Center Research; 🇺🇸 Huntsville, Alabama, United States

Cardiology Associates of Mobile; 🇺🇸 Mobile, Alabama, United States

John C Lincoln North Mountain Hospital; 🇺🇸 Phoenix, Arizona, United States

Chula Vista Cardiac Center; 🇺🇸 Chula Vista, California, United States

Cardiovascular Consultants Heart Center; 🇺🇸 Fresno, California, United States

Stanislaus Cardiology Group; 🇺🇸 Modesto, California, United States

Sutter Medical Center of Santa Rosa; 🇺🇸 Santa Rosa, California, United States

Exempla Rocky Mountain Cardiovascular Associates; 🇺🇸 Broomfield, Colorado, United States

South Denver Cardiology Associates PC; 🇺🇸 Littleton, Colorado, United States

Lakeland Regional Medical Center; 🇺🇸 Lakeland, Florida, United States

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