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OpenTrials
Completed

NCT Number: NCT01993862

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Center Research, Huntsville, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Same day discharge

Other

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.

Primary outcomes

  1. Complication rate at 1 week after an implantable cardioverter defibrillator implant

    Time frame: 1 week

Secondary outcomes

  1. Cost savings per patient

    Time frame: 1 week

  2. Complication rate at 6 months after an implantable cardioverter defibrillator implant

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Acronym: SDD for ICD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 25, 2013
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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