Use of Defibrillator Information in the Emergency Department

Congestive Heart Failure Clinical Trial

Official title:

Can Pacemakers, Defibrillators, and Internal Heart Failure Devices Be Used to Evaluate and Guide Management in the Emergency Department?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708058
• Other study ID #: 2007H0089
• Status: Completed
• Phase: N/A
• First received: June 27, 2008
• Last updated: March 19, 2012
• Start date: August 2007
• Est. completion date: March 2010

Study information

• Verified date: March 2012
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2010
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Emergencies
• Heart Failure
• Medical Device

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	To determine if there are better methods of making the device diagnostic information accessible to ED physicians/staff		During Emergency Department visit	No