Same Day Discharge (SDD) After Implantable Cardioverter Defibrillator (ICD) Implant
- Conditions
- Coronary Artery DiseaseHeart Failure
- Interventions
- Other: Same Day Discharge
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 266
- 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
- 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
- Arm && Interventions
Group Intervention Description Same Day Discharge 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.
- 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)
Loyola University Medical Center
๐บ๐ธMaywood, Illinois, United States
Cardiology Associates of Mobile
๐บ๐ธMobile, Alabama, United States
Exempla Rocky Mountain Cardiovascular Associates
๐บ๐ธBroomfield, Colorado, United States
Jackson Heart Clinic
๐บ๐ธJackson, Mississippi, United States
Chicago Cardiology Institute
๐บ๐ธSchaumburg, Illinois, United States
Missouri Baptist Medical Center
๐บ๐ธSaint Louis, Missouri, United States
Arrhythmia Associates of South Texas
๐บ๐ธSan Antonio, Texas, United States
John C Lincoln North Mountain Hospital
๐บ๐ธPhoenix, Arizona, United States
Chula Vista Cardiac Center
๐บ๐ธChula Vista, California, United States
Heart Center Research
๐บ๐ธHuntsville, Alabama, United States
Stanislaus Cardiology Group
๐บ๐ธModesto, California, United States
South Denver Cardiology Associates PC
๐บ๐ธLittleton, Colorado, United States
Florida Cardiovascular Specialists
๐บ๐ธLeesburg, Florida, United States
Lakeland Regional Medical Center
๐บ๐ธLakeland, Florida, United States
Thoracic Cardiovascular Healthcare Foundation
๐บ๐ธLansing, Michigan, United States
Delmarva Heart
๐บ๐ธSalisbury, Maryland, United States
The New York Hospital Queens
๐บ๐ธFlushing, New York, United States
St. Louis Heart and Vascular PC
๐บ๐ธSaint Louis, Missouri, United States
Cary Cardiology, PA
๐บ๐ธCary, North Carolina, United States
Cardiology Consultants
๐บ๐ธJohnson City, Tennessee, United States
St. Luke's Hospital - Roosevelt
๐บ๐ธNew York, New York, United States
Naples Heart Rhythm Specialists, PA
๐บ๐ธNaples, Florida, United States
Cardiovascular Consultants Heart Center
๐บ๐ธFresno, California, United States
Aurora Medical Group
๐บ๐ธMilwaukee, Wisconsin, United States
Sutter Medical Center of Santa Rosa
๐บ๐ธSanta Rosa, California, United States
Great Lakes Heart and Cascular Institute PC
๐บ๐ธSaint Joseph, Michigan, United States
Ochsner Medical Center
๐บ๐ธNew Orleans, Louisiana, United States
Watson Clinic Center
๐บ๐ธLakeland, Florida, United States