Overview

This trial is active, not recruiting.

Conditions heart failure, coronary artery disease
Treatments same day discharge, merlin.net
Sponsor St. Jude Medical
Start date December 2013
End date December 2016
Trial size 266 participants
Trial identifier NCT01993862, 40009529/B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(No Intervention)
The patient will have a 23 hour standard of care observational stay in the hospital after an implantable cardioverter defibrillator implant procedure.
(Active Comparator)
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.
same day discharge Merlin.net
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.
merlin.net

Primary Outcomes

Measure
Complication rate at 1 week after an implantable cardioverter defibrillator implant
time frame: 1 week

Secondary Outcomes

Measure
Cost savings per patient
time frame: 1 week
Complication rate at 6 months after an implantable cardioverter defibrillator implant
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Safety and Cost Effectiveness of Same Day Discharge After Implantable Cardioverter-Defibrillator Implant Versus Next Day Discharge
Principal investigator Indrajit Choudhuri, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.