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

January 31, 2019 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research
      • Mobile, Alabama, United States, 36608
        • Cardiology Associates of Mobile
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • John C Lincoln North Mountain Hospital
    • California
      • Chula Vista, California, United States, 91910
        • Chula Vista Cardiac Center
      • Fresno, California, United States, 93720
        • Cardiovascular Consultants Heart Center
      • Modesto, California, United States, 95355
        • Stanislaus Cardiology Group
      • Santa Rosa, California, United States, 95404
        • Sutter Medical Center of Santa Rosa
    • Colorado
      • Broomfield, Colorado, United States, 80021
        • Exempla Rocky Mountain Cardiovascular Associates
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates PC
    • Florida
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Medical Center
      • Lakeland, Florida, United States, 33805
        • Watson Clinic Center
      • Leesburg, Florida, United States, 34748
        • Florida Cardiovascular Specialists
      • Naples, Florida, United States, 34102
        • Naples Heart Rhythm Specialists, PA
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Schaumburg, Illinois, United States, 60173
        • Chicago Cardiology Institute
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Maryland
      • Salisbury, Maryland, United States, 21804
        • Delmarva Heart
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Thoracic Cardiovascular Healthcare Foundation
      • Saint Joseph, Michigan, United States, 49085
        • Great Lakes Heart and Cascular Institute PC
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Jackson Heart Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Saint Louis, Missouri, United States, 63136
        • St. Louis Heart and Vascular PC
    • New York
      • Flushing, New York, United States, 11355
        • The New York Hospital Queens
      • New York, New York, United States, 10025
        • St. Luke's Hospital - Roosevelt
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Cary Cardiology, PA
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Cardiology Consultants
    • Texas
      • San Antonio, Texas, United States, 78217
        • Arrhythmia Associates of South Texas
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complication rate at 1 week after an implantable cardioverter defibrillator implant
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost savings per patient
Time Frame: 1 week
1 week
Complication rate at 6 months after an implantable cardioverter defibrillator implant
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2014

Primary Completion (Actual)

August 5, 2016

Study Completion (Actual)

August 12, 2016

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40009529/B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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