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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01993862
First received: November 19, 2013
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Heart Failure
Coronary Artery Disease
Other: Same Day Discharge
Device: Merlin.net

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Safety and Cost Effectiveness of Same Day Discharge After Implantable Cardioverter-Defibrillator Implant Versus Next Day Discharge

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Complication rate at 1 week after an implantable cardioverter defibrillator implant [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cost savings per patient [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Complication rate at 6 months after an implantable cardioverter defibrillator implant [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Merlin.net
Device: Merlin.net

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01993862

Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Indrajit Choudhuri, MD University of Wisconsin, Madison
Principal Investigator: Ranjit Suri, MD Heart Rhythm Associates of New York, NY
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01993862     History of Changes
Other Study ID Numbers: 40009529/B
Study First Received: November 19, 2013
Last Updated: May 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Failure
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014