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

Abbott

Status: Completed

Conditions: Coronary Artery Disease; Heart Failure

Treatments: Other: Same Day Discharge

Study type: Interventional

Funder types: Industry

Identifiers

NCT01993862

40009529/B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 266 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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266 participants in 2 patient groups

Next Day Discharge

No Intervention group

Description:

The patient will have a 23 hour standard of care observational stay in the hospital after an implantable cardioverter defibrillator implant procedure.

Same Day Discharge

Active Comparator group

Description:

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.

Treatment:

Other: Same Day Discharge