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

NCT ID: NCT01993862

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-17
• Study Completion Date: 2016-08-12

Brief 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.

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.

Conditions

Heart Failure; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Same Day Discharge

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Indrajit Choudhuri, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Ranjit Suri, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Rhythm Associates of New York, NY

Locations

Heart Center Research

Huntsville, Alabama, United States

Cardiology Associates of Mobile

Mobile, Alabama, United States

John C Lincoln North Mountain Hospital

Phoenix, Arizona, United States

Chula Vista Cardiac Center

Chula Vista, California, United States

Cardiovascular Consultants Heart Center

Fresno, California, United States

Stanislaus Cardiology Group

Modesto, California, United States

Sutter Medical Center of Santa Rosa

Santa Rosa, California, United States

Exempla Rocky Mountain Cardiovascular Associates

Broomfield, Colorado, United States

South Denver Cardiology Associates PC

Littleton, Colorado, United States

Lakeland Regional Medical Center

Lakeland, Florida, United States

Watson Clinic Center

Lakeland, Florida, United States

Florida Cardiovascular Specialists

Leesburg, Florida, United States

Naples Heart Rhythm Specialists, PA

Naples, Florida, United States

Loyola University Medical Center

Maywood, Illinois, United States

Chicago Cardiology Institute

Schaumburg, Illinois, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Delmarva Heart

Salisbury, Maryland, United States

Thoracic Cardiovascular Healthcare Foundation

Lansing, Michigan, United States

Great Lakes Heart and Cascular Institute PC

Saint Joseph, Michigan, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

St. Louis Heart and Vascular PC

St Louis, Missouri, United States

The New York Hospital Queens

Flushing, New York, United States

St. Luke's Hospital - Roosevelt

New York, New York, United States

Cary Cardiology, PA

Cary, North Carolina, United States

Cardiology Consultants

Johnson City, Tennessee, United States

Arrhythmia Associates of South Texas

San Antonio, Texas, United States

Aurora Medical Group

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

40009529/B

Identifier Type: -

Identifier Source: org_study_id