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



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:March 17, 2014
End Date:August 12, 2016

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

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.

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.

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
We found this trial at
28
sites
Huntsville, Alabama 35801
1785
mi
from 91732
Huntsville, AL
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816
mi
from 91732
Broomfield, CO
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Cary, North Carolina 27518
2210
mi
from 91732
Cary, NC
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Chula Vista, California 91910
113
mi
from 91732
Chula Vista, CA
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Flushing, New York 11355
2442
mi
from 91732
Flushing, NY
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Fresno, California 93720
209
mi
from 91732
Fresno, CA
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Jackson, Mississippi 39216
1609
mi
from 91732
Jackson, MS
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Johnson City, Tennessee 37601
2008
mi
from 91732
Johnson City, TN
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2163
mi
from 91732
Lakeland, FL
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Lakeland, Florida 33805
2163
mi
from 91732
Lakeland, FL
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1893
mi
from 91732
Lansing, MI
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Leesburg, Florida 34748
2149
mi
from 91732
Leesburg, FL
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Littleton, Colorado 80120
813
mi
from 91732
Littleton, CO
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
1719
mi
from 91732
Maywood, IL
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Milwaukee, Wisconsin 14450
1729
mi
from 91732
Milwaukee, WI
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Mobile, Alabama 36608
1740
mi
from 91732
Mobile, AL
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Modesto, California 95355
297
mi
from 91732
Modesto, CA
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Naples, Florida 34102
2220
mi
from 91732
Naples, FL
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
1650
mi
from 91732
New Orleans, LA
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New York, New York 10025
2351
mi
from 91732
New York, NY
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343
mi
from 91732
Phoenix, AZ
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Saint Joseph, Michigan 49085
1790
mi
from 91732
Saint Joseph, MI
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
1559
mi
from 91732
Saint Louis, MO
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Saint Louis, Missouri 63136
1573
mi
from 91732
Saint Louis, MO
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Salisbury, Maryland 21804
2361
mi
from 91732
Salisbury, MD
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San Antonio, Texas 78217
1189
mi
from 91732
San Antonio, TX
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Santa Rosa, California 95404
199
mi
from 91732
Santa Rosa, CA
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Schaumburg, Illinois 60173
1708
mi
from 91732
Schaumburg, IL
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