Same Day Discharge (SDD) After Implantable Cardioverter Defibrillator (ICD) Implant
SDD for ICD
Safety and Cost Effectiveness of Same Day Discharge After Implantable Cardioverter-Defibrillator Implant Versus Next Day Discharge
1 other identifier
interventional
266
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Mar 2014
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedStudy Start
First participant enrolled
March 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2016
CompletedFebruary 4, 2019
January 1, 2019
2.4 years
November 19, 2013
January 31, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Complication rate at 1 week after an implantable cardioverter defibrillator implant
1 week
Secondary Outcomes (2)
Cost savings per patient
1 week
Complication rate at 6 months after an implantable cardioverter defibrillator implant
6 months
Study Arms (2)
Next Day Discharge
NO INTERVENTIONThe patient will have a 23 hour standard of care observational stay in the hospital after an implantable cardioverter defibrillator implant procedure.
Same Day Discharge
ACTIVE COMPARATORThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Heart Center Research
Huntsville, Alabama, 35801, United States
Cardiology Associates of Mobile
Mobile, Alabama, 36608, United States
John C Lincoln North Mountain Hospital
Phoenix, Arizona, 85020, United States
Chula Vista Cardiac Center
Chula Vista, California, 91910, United States
Cardiovascular Consultants Heart Center
Fresno, California, 93720, United States
Stanislaus Cardiology Group
Modesto, California, 95355, United States
Sutter Medical Center of Santa Rosa
Santa Rosa, California, 95404, United States
Exempla Rocky Mountain Cardiovascular Associates
Broomfield, Colorado, 80021, United States
South Denver Cardiology Associates PC
Littleton, Colorado, 80120, United States
Lakeland Regional Medical Center
Lakeland, Florida, 33805, United States
Watson Clinic Center
Lakeland, Florida, 33805, United States
Florida Cardiovascular Specialists
Leesburg, Florida, 34748, United States
Naples Heart Rhythm Specialists, PA
Naples, Florida, 34102, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Chicago Cardiology Institute
Schaumburg, Illinois, 60173, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Delmarva Heart
Salisbury, Maryland, 21804, United States
Thoracic Cardiovascular Healthcare Foundation
Lansing, Michigan, 48912, United States
Great Lakes Heart and Cascular Institute PC
Saint Joseph, Michigan, 49085, United States
Jackson Heart Clinic
Jackson, Mississippi, 39216, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
St. Louis Heart and Vascular PC
St Louis, Missouri, 63136, United States
The New York Hospital Queens
Flushing, New York, 11355, United States
St. Luke's Hospital - Roosevelt
New York, New York, 10025, United States
Cary Cardiology, PA
Cary, North Carolina, 27518, United States
Cardiology Consultants
Johnson City, Tennessee, 37601, United States
Arrhythmia Associates of South Texas
San Antonio, Texas, 78217, United States
Aurora Medical Group
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Indrajit Choudhuri, MD
University of Wisconsin, Madison
- PRINCIPAL INVESTIGATOR
Ranjit Suri, MD
Heart Rhythm Associates of New York, NY
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2013
First Posted
November 25, 2013
Study Start
March 17, 2014
Primary Completion
August 5, 2016
Study Completion
August 12, 2016
Last Updated
February 4, 2019
Record last verified: 2019-01