Use of Defibrillator Information in the Emergency Department

Completed

• Conditions: Congestive Heart Failure; Medical Device

• Registration Number: NCT00708058
• Lead Sponsor: Ohio State University

Brief Summary

This is a study to determine the feasibility of obtaining information stored in existing Medtronic internal defibrillators in patients who present to the Emergency Department(ED) for any reason. In addition, the study will determine if this information is useful to the ED physician in managing the patient's care, specifically as it relates to heart failure.

Detailed Description

This is a prospective observational pilot study to determine if stored data regarding heart function, patient activity level, and other parameters can be used by the ED physician in order to evaluate a patient's cardiac status as it pertains to heart failure. Patients presenting to the ED and who consent have their devices interrogated by research personnel. The data is printed and provided to the treating physician who completes a brief survey about whether the data was useful in managing the patient.All subjects are contacted 30 days after ED or hospital discharge to determine if they have had any ED visits or hospital admissions during that period, and if yes, whether the visits were heart failure related. After all study procedures are performed, a team of 2 cardiologists will review the patient medical record from the study visit, as well as the data obtained from the patient's device in the ED. Each cardiologist, who will be blinded to the other's conclusion, will determine if the patient was having a heart failure exacerbation at the study visit.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-07-02
• Primary Completion: 2008-09
• Study Completion: 2010-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-19
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• age 18 or older
• Medtronic IACD present on arrival to Emergency Dept.

Exclusion Criteria

• minors
• prisoners
• non-Medtronic AICD
• unable to provide consent
• no telephone for 30 day follow up call

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if Medtronic implantable device diagnostics can be used in conjunction with clinical exam to diagnose and guide Emergency Department care	During Emergency Dept. visit
To determine if there are better methods of making the device diagnostic information accessible to ED physicians/staff	During Emergency Department visit

Trial Locations

Locations (1)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States