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 |
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.
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.
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
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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