Clinical trial NCT01993862: Same Day Discharge (SDD) After Implantable Cardioverter Defibrillator (ICD) Implant
Official title: Safety and Cost Effectiveness of Same Day Discharge After Implantable Cardioverter-Defibrillator Implant Versus Next Day Discharge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Coronary Artery Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Complication rate at 1 week after an implantable cardioverter defibrillator implant
timeFrame: 1 week
Secondary outcomes:
measure: Cost savings per patient
timeFrame: 1 week
measure: Complication rate at 6 months after an implantable cardioverter defibrillator implant
timeFrame: 6 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research
state: Alabama
city: Mobile
country: United States
facility: Cardiology Associates of Mobile
state: Alabama
city: Phoenix
country: United States
facility: John C Lincoln North Mountain Hospital
state: Arizona
city: Chula Vista
country: United States
facility: Chula Vista Cardiac Center
state: California
city: Fresno
country: United States
facility: Cardiovascular Consultants Heart Center
state: California
city: Modesto
country: United States
facility: Stanislaus Cardiology Group
state: California
city: Santa Rosa
country: United States
facility: Sutter Medical Center of Santa Rosa
state: California
city: Broomfield
country: United States
facility: Exempla Rocky Mountain Cardiovascular Associates
state: Colorado
city: Littleton
country: United States
facility: South Denver Cardiology Associates PC
state: Colorado
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic Center
state: Florida
city: Leesburg
country: United States
facility: Florida Cardiovascular Specialists
state: Florida
city: Naples
country: United States
facility: Naples Heart Rhythm Specialists, PA
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Schaumburg
country: United States
facility: Chicago Cardiology Institute
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Salisbury
country: United States
facility: Delmarva Heart
state: Maryland
city: Lansing
country: United States
facility: Thoracic Cardiovascular Healthcare Foundation
state: Michigan
city: Saint Joseph
country: United States
facility: Great Lakes Heart and Cascular Institute PC
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular PC
state: Missouri
city: Flushing
country: United States
facility: The New York Hospital Queens
state: New York
city: New York
country: United States
facility: St. Luke's Hospital - Roosevelt
state: New York
city: Cary
country: United States
facility: Cary Cardiology, PA
state: North Carolina
city: Johnson City
country: United States
facility: Cardiology Consultants
state: Tennessee
city: San Antonio
country: United States
facility: Arrhythmia Associates of South Texas
state: Texas
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Indrajit Choudhuri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Rhythm Associates of New York, NY
name: Ranjit Suri, MD
role: PRINCIPAL_INVESTIGATOR
References: