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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01993862
First Posted: November 25, 2013
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
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 Intervention
Heart Failure Coronary Artery Disease Other: Same Day Discharge

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Complication rate at 1 week after an implantable cardioverter defibrillator implant [ Time Frame: 1 week ]

Secondary Outcome Measures:
  • Cost savings per patient [ Time Frame: 1 week ]
  • Complication rate at 6 months after an implantable cardioverter defibrillator implant [ Time Frame: 6 months ]

Enrollment: 266
Actual Study Start Date: March 17, 2014
Study Completion Date: August 12, 2016
Primary Completion Date: August 5, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993862


  Show 28 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Indrajit Choudhuri, MD University of Wisconsin, Madison
Principal Investigator: Ranjit Suri, MD Heart Rhythm Associates of New York, NY
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01993862     History of Changes
Other Study ID Numbers: 40009529/B
First Submitted: November 19, 2013
First Posted: November 25, 2013
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases