Same Day Discharge (SDD) After Implantable Cardioverter Defibrillator (ICD) Implant (SDD for ICD)
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|ClinicalTrials.gov Identifier: NCT01993862|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Coronary Artery Disease||Other: Same Day Discharge||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Safety and Cost Effectiveness of Same Day Discharge After Implantable Cardioverter-Defibrillator Implant Versus Next Day Discharge|
|Actual Study Start Date :||March 17, 2014|
|Actual Primary Completion Date :||August 5, 2016|
|Actual Study Completion Date :||August 12, 2016|
No Intervention: Next Day Discharge
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
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
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.
- Complication rate at 1 week after an implantable cardioverter defibrillator implant [ Time Frame: 1 week ]
- Cost savings per patient [ Time Frame: 1 week ]
- Complication rate at 6 months after an implantable cardioverter defibrillator implant [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993862
Show 28 Study Locations
|Principal Investigator:||Indrajit Choudhuri, MD||University of Wisconsin, Madison|
|Principal Investigator:||Ranjit Suri, MD||Heart Rhythm Associates of New York, NY|