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

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT01993862

Collaborator

(none)

266

Enrollment

Locations

Arms

28.9

Actual Duration (Months)

9.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Coronary Artery Disease	Other: Same Day Discharge	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

266 participants

Allocation:

Randomized

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 :

Mar 17, 2014

Actual Primary Completion Date :

Aug 5, 2016

Actual Study Completion Date :

Aug 12, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Complication rate at 1 week after an implantable cardioverter defibrillator implant [1 week]

Secondary Outcome Measures

Cost savings per patient [1 week]
Complication rate at 6 months after an implantable cardioverter defibrillator implant [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center Research	Huntsville	Alabama	United States	35801
2	Cardiology Associates of Mobile	Mobile	Alabama	United States	36608
3	John C Lincoln North Mountain Hospital	Phoenix	Arizona	United States	85020
4	Chula Vista Cardiac Center	Chula Vista	California	United States	91910
5	Cardiovascular Consultants Heart Center	Fresno	California	United States	93720
6	Stanislaus Cardiology Group	Modesto	California	United States	95355
7	Sutter Medical Center of Santa Rosa	Santa Rosa	California	United States	95404
8	Exempla Rocky Mountain Cardiovascular Associates	Broomfield	Colorado	United States	80021
9	South Denver Cardiology Associates PC	Littleton	Colorado	United States	80120
10	Lakeland Regional Medical Center	Lakeland	Florida	United States	33805
11	Watson Clinic Center	Lakeland	Florida	United States	33805
12	Florida Cardiovascular Specialists	Leesburg	Florida	United States	34748
13	Naples Heart Rhythm Specialists, PA	Naples	Florida	United States	34102
14	Loyola University Medical Center	Maywood	Illinois	United States	60153
15	Chicago Cardiology Institute	Schaumburg	Illinois	United States	60173
16	Ochsner Medical Center	New Orleans	Louisiana	United States	70121
17	Delmarva Heart	Salisbury	Maryland	United States	21804
18	Thoracic Cardiovascular Healthcare Foundation	Lansing	Michigan	United States	48912
19	Great Lakes Heart and Cascular Institute PC	Saint Joseph	Michigan	United States	49085
20	Jackson Heart Clinic	Jackson	Mississippi	United States	39216
21	Missouri Baptist Medical Center	Saint Louis	Missouri	United States	63131
22	St. Louis Heart and Vascular PC	Saint Louis	Missouri	United States	63136
23	The New York Hospital Queens	Flushing	New York	United States	11355
24	St. Luke's Hospital - Roosevelt	New York	New York	United States	10025
25	Cary Cardiology, PA	Cary	North Carolina	United States	27518
26	Cardiology Consultants	Johnson City	Tennessee	United States	37601
27	Arrhythmia Associates of South Texas	San Antonio	Texas	United States	78217
28	Aurora Medical Group	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

Abbott Medical Devices

Investigators

Principal Investigator: Indrajit Choudhuri, MD, University of Wisconsin, Madison
Principal Investigator: Ranjit Suri, MD, Heart Rhythm Associates of New York, NY

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abbott Medical Devices

ClinicalTrials.gov Identifier:

NCT01993862

Other Study ID Numbers:

40009529/B

First Posted:

Nov 25, 2013

Last Update Posted:

Feb 4, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Feb 4, 2019