Same Day Discharge (SDD) After Implantable Cardioverter Defibrillator (ICD) Implant

Coronary Artery Disease Clinical Trial

— SDD for ICD  

Official title:

Safety and Cost Effectiveness of Same Day Discharge After Implantable Cardioverter-Defibrillator Implant Versus Next Day Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993862
• Other study ID #: 40009529/B
• Status: Completed
• Phase: N/A
• Start date: March 17, 2014
• Est. completion date: August 12, 2016

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: August 12, 2016
• Est. primary completion date: August 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Exempla Rocky Mountain Cardiovascular Associates	Broomfield	Colorado
United States	Cary Cardiology, PA	Cary	North Carolina
United States	Chula Vista Cardiac Center	Chula Vista	California
United States	The New York Hospital Queens	Flushing	New York
United States	Cardiovascular Consultants Heart Center	Fresno	California
United States	Heart Center Research	Huntsville	Alabama
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Cardiology Consultants	Johnson City	Tennessee
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	Watson Clinic Center	Lakeland	Florida
United States	Thoracic Cardiovascular Healthcare Foundation	Lansing	Michigan
United States	Florida Cardiovascular Specialists	Leesburg	Florida
United States	South Denver Cardiology Associates PC	Littleton	Colorado
United States	Loyola University Medical Center	Maywood	Illinois
United States	Aurora Medical Group	Milwaukee	Wisconsin
United States	Cardiology Associates of Mobile	Mobile	Alabama
United States	Stanislaus Cardiology Group	Modesto	California
United States	Naples Heart Rhythm Specialists, PA	Naples	Florida
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	St. Luke's Hospital - Roosevelt	New York	New York
United States	John C Lincoln North Mountain Hospital	Phoenix	Arizona
United States	Great Lakes Heart and Cascular Institute PC	Saint Joseph	Michigan
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	St. Louis Heart and Vascular PC	Saint Louis	Missouri
United States	Delmarva Heart	Salisbury	Maryland
United States	Arrhythmia Associates of South Texas	San Antonio	Texas
United States	Sutter Medical Center of Santa Rosa	Santa Rosa	California
United States	Chicago Cardiology Institute	Schaumburg	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate at 1 week after an implantable cardioverter defibrillator implant		1 week
Secondary	Cost savings per patient		1 week
Secondary	Complication rate at 6 months after an implantable cardioverter defibrillator implant		6 months